University of Southern Denmark

Effect of family nursing therapeutic conversations on health-related quality of life, self-care

and depression among outpatients with heart failure
A randomized multi-centre trial
Østergaard, Birte; Mahrer-Imhof, Romy; Wagner, Lis; Barington, Torben; Videbæk, Lars;
Lauridsen, Jørgen

Published in:
Patient Education and Counseling

DOI:
10.1016/j.pec.2018.03.006

Publication date:
2018

Document version:
Accepted manuscript

Document license:
CC BY-NC-ND

Citation for pulished version (APA):

Østergaard, B., Mahrer-Imhof, R., Wagner, L., Barington, T., Videbæk, L., & Lauridsen, J. (2018). Effect of family
nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients
with heart failure: A randomized multi-centre trial. Patient Education and Counseling, 101(8), 1385-1393.
https://doi.org/10.1016/j.pec.2018.03.006

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Accepted Manuscript

Title: Effect of family nursing therapeutic conversations on

health-related quality of life, self-care and depression among
outpatients with heart failure: A randomized multi-centre trial

Authors: Birte Østergaard, Romy Mahrer-Imhof, Lis Wagner,

Torben Barington, Lars Videbæk, Jørgen Lauridsen

PII: S0738-3991(18)30110-1
DOI: https://doi.org/10.1016/j.pec.2018.03.006
Reference: PEC 5908

To appear in: Patient Education and Counseling

Received date: 17-8-2017

Revised date: 23-2-2018
Accepted date: 4-3-2018

Please cite this article as: Østergaard Birte, Mahrer-Imhof Romy, Wagner Lis,
Barington Torben, Videbæk Lars, Lauridsen Jørgen.Effect of family nursing therapeutic
conversations on health-related quality of life, self-care and depression among
outpatients with heart failure: A randomized multi-centre trial.Patient Education and
Counseling https://doi.org/10.1016/j.pec.2018.03.006

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Title: Effect of family nursing therapeutic conversations on health-related quality of life, self-

care and depression among outpatients with heart failure: A randomized multi-centre trial

Birte Østergaarda,c, Romy Mahrer-Imhofb, Lis Wagnera, Torben Baringtonc Lars Videbækd, Jørgen

Lauridsene

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a
Department of Clinical Research, University of Southern Denmark, Odense Denmark

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b
Nursing Science & Care Ltd, Winterthur; Institute of Nursing, Zurich University of Applied

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Sciences, Winterthur, Switzerland
c
OPEN Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark
d
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Department of Cardiology, Odense University Hospital, Odense, Denmark
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e
COHERE, Department of Business and Economics, University of Southern Denmark, Odense,
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Denmark
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Corresponding Author: Birte Østergaard, PhD, Department of Clinical Research, University of

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Southern Denmark, Campusvej 55, DK-5230 Odense M, Denmark

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E-mail: boestergaard@health.sdu.dk, Phone: +45 6550 4053

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Word count in abstract: 199

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Word count in text: 4000

Number of tables: 4
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Numbers of figures: 1

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Highlights

 Effectiveness of family-focused care was self-rated by outpatients with heart failure

 FNTCs did not lead to better care of outpatients with heart failure

 More research is needed regarding the use of FNTCs as supplement to treatment of

outpatients with HF

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Abstract

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Objective: To evaluate the short-term (3 months) effects of family nursing therapeutic

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conversations (FNTC) on health-related quality of life, self-care and depression in outpatients with

Heart failure (HF).

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Methods: A randomised multi-centre trial was conducted in three Danish HF clinics. The control
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group (n = 167) received usual care, and the intervention group (n = 180) received FNTCs as
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supplement to usual care. Primary outcome was clinically significant changes (6 points) in Kansas
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City Cardiomyopathy Questionnaire (KCCQ) summary score between groups. Secondary outcomes
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were changes in self-care behaviour and depression scores. Data were assessed before first

consultation and repeated after three months.

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Results: No statistically significant difference was found in the change of KCCQ, self-care and

depression scores between the groups. KCCQ scores of patients in the FNTC group changed
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clinically significant in seven domains, compared to one domain in the control group, with the
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highest improvement in self-efficacy, social limitation and symptom burden.

Conclusion: FNTC was not superior to standard care of patients with HF regarding health-related
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quality of life, self-care and depression.

Implication for practice: Addressing the impact of the disease on the family, might improve self-

efficacy, social limitation and symptom burden in patients with heart failure.

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Key words: Family nursing therapeutic conversations, heart failure, randomized multi-centre trial

1. Introduction

Heart failure (HF) is estimated to affect 26 million people worldwide, 15 million of whom live in

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European countries [1]. The condition is among the leading causes of morbidity and mortality and

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confers a substantial burden to the health-care system [2, 3].

Psycho-social factors have been identified as influencing self-care and survival of patients with HF

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[4], and factors such as anxiety [5], depression [6] and quality of life [7] was related to morbidity

and mortality independent of medical risk factors. Furthermore, HF has a significant impact on the

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lives of patients [4, 8] and their close relatives [9, 10], and quality of life is impaired in both
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patients [11] and their partners [12, 13].
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The influence of close relatives on the well-being of patients with HF is known [14], and high
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matrimonial quality was found to significantly improve 8-year survival in patients [15]; however,

communication regarding relational emotions, sexual concerns, changes in domestic roles and
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adjustment to illness are often insufficient amongst the patient-partner dyad [16].

A family-centred approach shows positive effects on patients’ physical and mental health [17, 18].
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Despite the reluctance of nurses to actively involve family members in patient care [19], cardiac
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nurses should include family members in psycho-educational initiatives together with the patients
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[2, 20-22]. Studies have shown improved patient outcomes in terms of adherence to salt restriction,

confidence, autonomous motivation, depression, family functioning and self-care [23-25].

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A randomised trial (155 patient-partner dyads) to evaluate the effects of psycho-educational support

in patients with HF and their partners suggests that it may be beneficial for the patients by

increasing their perceived control [26]. A pilot study exploring the effects of three multidisciplinary

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psycho-educational sessions among 42 patients with HF and their partners found no significant

effect of the intervention on the partners’ perceptions of caregiver burden [27].

The previous studies investigating the effect of psycho-social support for patients with HF used

differing definitions of psycho-social support, were mainly carried out as single centre studies using

a descriptive design in small patient populations, and reports diverging results [13, 23-25]. Focusing

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on family challenges related to the illness can relieve patients and family members’ pressing

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dilemmas and thus their depressive symptoms [17, 28], and might also influence patients’ quality of

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life. Consequently, there is a need for large scale randomised multi-centre trials before it can be

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finally concluded whether a family-centred approach would be of benefit to patients with HF.

Therefore, this Heart Failure Family (HFF) trial [29] was conducted to test the effects of a family-

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focused nursing intervention, in the form of family nursing therapeutic conversations (FNTCs), on
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health-related quality of life, illness management (self-care, family resources and depression), re-
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admissions and the mortality of outpatients with HF. In this article, we used only data regarding
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patient outcomes and we report the short-term (3-months) effect of FNTC on health-related quality

of life, self-care and depression. Data regarding dyadic effects on family functioning will be
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reported in a separate paper.

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2. Methods
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2.1. Design
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The HFF trial was conducted as a non-pharmacological randomised clinical multicentre trial

with parallel-groups in which patients were followed concurrently, and assigned to either a
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control group or a treatment group that received FNTC in addition to conventional care [30,

31].

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2.2. Setting, study population and randomisation

Patients from three Danish HF outpatient clinics located in the region of Southern Denmark and the

Capital Region were screened consecutively for eligibility from June 2010 to January 2016.

Inclusion criteria were: confirmation of the HF diagnosis in accordance with the Framingham

criteria [32], left ventricular ejection fraction (LVEF) ≤ 40%, referred to follow-up nursing care in a

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HF clinic, New York Heart Association (NYHA) classification II–IV symptoms [33]. Patients who

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did not understand and speak Danish, or were in the terminal stage of another disease with a life

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expectancy of less than 6 months, or were not able to give informed consent were excluded from the

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trial. All patients gave verbal and written informed consent before they were randomised to one of

two groups by an external web-based system and stratified by NYHA classification and HF clinics.

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The allocation sequence and block sizes were concealed from the investigators. Concealment of the
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intervention from the patients, project nurses and other care providers was not possible but
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independent assessors of outcomes and the staff undertaking data analysis were blinded for
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allocation.
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2.3. Conventional treatment

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All patients received standard treatment by health professionals specialised in heart failure. There

was no pivotal difference in reference pattern or staff resources between the three HF clinics [34].
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Basic principles for the treatment consisted of a preliminary clinical assessment of the patient by
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consulting cardiologists, followed by continued treatment in the nurse-led HF clinics for up-titration

and adjustment of the pharmacological medication according to pre-specified regulations, telephone

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consultations and patient education. Special attention was given to the training of the patient in self-

care regarding daily weighing, reaction to increased weight, flexible diuretic treatment, medical up-

titration and adjustment, possibilities for acute contact to the hospital and possibilities for

5
intravenous treatment on an outpatient basis. Moreover, the patient received information and

guidance about the cause of the HF, symptoms, rationale for the treatment, smoking cessation,

exercise, rest, diet, travelling, vaccinations, and psycho-social reactions towards the illness. The

treatment concept was developed on the basis of international [2] and national [35] guidelines.

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2.4. Intervention

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FNTCs were performed in addition to the conventional care of the patients. The family members

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were identified by the patients and informed verbally and in writing about the study. The FNTC

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sessions were based on the Calgary Family Assessment and Intervention Models [36]. They were

considered to be feasible as an addition to the routine outpatient care of HF where family members

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are not always able to participate [37], because FNTCs can also be used to gain a family perspective
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on the impact of the illness on family life and relationships (marriage, work, children etc.) when
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only the patient or the patient and his/her partner is present [36]. Focus is on interaction and
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reciprocity between family members and between the nurse and the family, which requires

acceptance of a multitude of opinions, beliefs and actions [38]. Family is defined in accordance
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with Wall [39], who states that a family consists of two or more individuals functioning in a way
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that they perceive themselves to be a family, and may be bound by blood ties or law, or not. In

practice, it is the patient who defines what he or she considers as family. Thus, family members
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might also include neighbours or good friends.

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The FNTCs were performed in a non-judgmental interactive relationship between the nurses and the

families, acknowledging the family’s unique perspective where the family is the expert in the
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members own life [40]. The sessions were led by HF-specialised nurses who had completed an

intensive educational and practical training programme before they were permitted to treat patients

in the trial. Furthermore, the project nurses participated in supervision sessions with the project

6
leader every second or third month in addition to participation in an international family nursing

conference, workshop and lectures.

Each family was offered on average three sessions over a period of 6 to 12 weeks, depending on

their needs [41]. At the first session, a genogram was drawn reflecting a picture of family structure

and social relationships [42]. Each family member was encouraged to tell their illness narrative and

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to reflect upon their beliefs about the HF diagnosis. They were also asked about which issues and

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problems they considered as being the most important and their expectations regarding the meeting.

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Future goals were identified, and the impact of the illness on the family unit as well as on the

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individual member’s daily life was discussed. Because the sessions were tailored to the needs of the

family and its members, only function and process of the intervention could be standardised but not

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the components themselves [43] (Table 1). Therefore, the content of each of the conversations was
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documented by the project nurses in case reports specially constructed for the HFF trial. Analysis of
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the case reports indicates that the essence of the conversations was concentrated on the possibility
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to express beliefs about the illness, reactions toward the illness and the impact on life, possibility to

reflect on past and future and learning to live with the illness [37].
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At the second and the following sessions, the project nurse asked what had happened since their last
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meeting. Based on the goals identified at the previous session, the family was encouraged to choose

the agenda for the conversation. FNTC in addition to conventional care required approximately 1
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hour, whereas conventional care in the HF clinic was scheduled to take approximately 30 minutes.
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2.5. Outcomes
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The primary outcome was defined as occurrence of clinically significant (CS) changes (6 points) in

the Kansas City Cardiomyopathy Questionnaire (KCCQ) summery score. Secondary outcomes

were changes in self-care behaviour and depression scores.

7
2.6. Measurements

The KCCQ is a self-administrated 23-item disease-specific questionnaire measuring quality of life

among patients with HF [44]. The instrument quantifies seven domains regarding physical

limitations, symptom stability, symptom frequency, symptom burden, self-efficacy, social

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limitations and quality of life. Additionally, four summary scores were calculated regarding total

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symptoms (average of symptom frequency and symptom burden), clinical summary (average of

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physical limitation and total symptoms), non-clinical summary (average of social limitations and

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quality of life) and overall summary (average of physical limitation, total symptoms, quality of life,

and social limitation). Scores ranged from 0 to 100, higher scores indicating better function, fewer

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symptoms and better quality of life [44, 45]. The instrument is sensitive to clinical changes [46],
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and a mean difference between groups of patients and an intra-individual change over time of ≥5
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point is considered CS [47]. Cronbach’s alpha for the internal consistency of the KCCQ is 0.93 for
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the overall score [47] and varies between 0.95 and 0.62 within the seven domains [44]. The

instrument exists in a Danish version, and Cronbach’s alpha for this study was 0.91.
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The European Heart Failure Self-care Behaviour Scale (EHFScB) [48] is extensively used [49] for
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assessment of self-care behaviours regarding adherence to medical treatment, diet, exercise,

symptoms, daily weighing, fluid restrictions and search for help if impaired symptoms occur. The
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revised EHFScB-9 [50] is rated on a 5-point Likert scale ranging from ‘I completely agree’ to ‘I
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don’t agree at all’. The sum score ranges from 9 to 45, with lower scores indicating better self-care.

The scale is easy to administer and tested for validity and reliability in a Danish population of
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patients with HF with the most superior fit for the two-factor solution (Adherence to regimen and

Consulting behaviour) with a Cronbach’s alpha at 0.47 and 0.84 respectively. Cronbach’s alpha for

the total scale was 0.77 [51].

8
The Major Depression Inventory (MDI) diagnostic scale can be used to identify clinical depression

[52]. The instrument consists of a 10-item self-rating list in which symptoms are scored on a 6-point

Likert scale ranging from ‘All the time’ to ‘At no time’. It was tested for validity among patients

with different stages of depression with Cronbach’s alpha for the internal consistency at 0.90 [53],

and previously used among patients undergoing heart surgery [54] and a Danish general population

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[55]. The MDI score was accumulated for the 10 items and ranged from 0 to 50. Two items

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(questions 8 and 10) were divided into sub-items (a and b), and the higher sub-score for each

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question was used to calculate the aggregated score. An aggregated score above 25 was interpreted

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as indicating depression [52].

2.7. Sample size

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The sample size was based on an expected minimal important difference in mean score of the
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KCCQ of 61 in the control group and 67 in the FNTC group. Standard deviation (SD) for the whole
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population was estimated to be 20. The calculation was based on normal distribution with α = 5%,

1-β = 10% and equal numbers of patients in both groups. In total 468 patients were needed.
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2.8. Data collection procedure

The HFF trial conforms with the Declaration of Helsinki [56]. It was registered in the
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ClinicalTrials.gov registry (identifier NCT00120991), The Danish Data Protection Agency (J.nr.
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2012-54-0140) and approved by The Regional Committees on Health Research Ethics for Southern

Denmark (journal no. 01-079/02). The project nurses at each centre screened for eligibility, and
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suitable patients were asked to participate. All patients received verbal and written information

about the study, were assured of confidentiality and could withdraw from the study at any time

without consequences for their future care. After they had given written informed consent,

9
questionnaires were handed out in paper form prior to first consultation with the project nurses. The

questionnaires at 3-month follow-up were posted or e-mailed to the patients by trial managing staff

not involved in the clinics or the care of the patients. Completed questionnaires were returned to the

researchers using prepaid envelopes. If the patients did not return the questionnaire, or expressed

problems filling in the questionnaire, a personal telephone interview was conducted. Demographics

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were collected from the patients or retrieved from medical records. Demographics from family

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members were collected from the questionnaires.

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2.9. Data processing and Analysis

Data were coded and entered IBM SPSS statistical program version 24 for descriptive statistics and

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SAS version 9.2 for analysis of changes in KCCQ, self-care behaviour and depression scores. The
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generation of scores for each domain of the KCCQ and handling of missing data were done in
A
accordance with the KCCQ scoring manual. Missing data in the EHFScB-9 and MDI scales were
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substituted with the mean score of the single item. We used a difference-in-difference (DID)

analysis [57] for both the primary and secondary outcomes. The scores are presented with means
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and standard deviations (SD). Descriptive statistics, including means, SD, numbers (n) and
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percentages (%) were administered to summarise the sociodemographic and clinical characteristics

of the patients. Categorical variables were compared using Pearson’s chi-square test or Fisher’s
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exact test, as appropriate. For continuous data, t-tests and chi-squared tests were used to assess
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mean difference in baseline characteristics between the two groups. A p-value of ≤ 0.05 was

considered statistically significant (SS).

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3. Results

3.1. Patient flow and patient characteristics

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The CONSORT diagram (Figure 1) reflects the flow of participants throughout the study. A total of

468 patients with HF were enrolled in the study and 347 (74%) completed the 3-month follow-up

questionnaire. Among the 155 who were excluded due to other reasons, 128 were discharged at first

consultation in the heart failure clinics, three were participating in other projects, and 24 were not

included due to logistic reasons. Of the 468 patients who were randomised to one of the two groups,

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50 withdrew before baseline assessment (with no data existing on two of the patients) and five died.

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The mean age of all patients was 66.7 (12.4) years, 74 % were men, 80% were classified as NYHA

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group II, and the mean LVEF was 27.5 (8.7). There were no SS baseline differences between the

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two groups, except that more patients in the conventional group had atrial fibrillation (p = 0.009)

(Table 2). Of the patients who did not complete the questionnaires, more in the conventional care

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group had a basic school education of 7 years or less than in the FNTC group (p = 0.04). The mean
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age was 66.7 (14.1), 69% were men, 82% were classified as NYHA II, and the mean LVEF was
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26.5 (9.1) (Table 2).
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Comparisons of baseline characteristics between the patients who did and did not complete the

questionnaires showed significant differences regarding being married χ² (1) = 6.29, p = 0.01 and
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self-employed χ² (1) =4.07, p = 0.04.

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3.2. FNTC
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In total, 632 conversations were carried out within the first 3 months, with an average number of
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2.72 (range 1–8) conversations per patient. The distribution of conversations and average number

of conversations per patient at each centre were: centre 1; 216 conversations (average 2.8; range 1–
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8); centre 2; 275 conversations (average 2.96; range 1–5) and centre 3; 141 conversations (average

2.27; range 1–5). The mean age of all family members was 61.8 (25.1) years, 79% were female, and

80% were spouses (Table 3). Most of the family members who participated in the conversations

11
were spouses (53%), followed by daughters (11%), sons (2%) and friends (2%), while 27% of the

conversations were carried out without any relative present.

3.3. Health-related quality of life

For the primary outcome, a CS change of 6 in the overall summary score was obtained in the FNTC

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group during the 3-month follow-up. In the control group, the changes reached a level of 5.1. The

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difference between the groups was not SS.

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For all patients, there was a SS improvement in nine of the 11 KCCQ domains (p < 0.01). In

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contrast, there was a decline in symptom stability scores, with the highest deterioration in the FNTC

group and an interaction effect of -2.278.

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Patients in the FNTC group improved more in seven domains compared to patients allocated to
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conventional care, with the highest improvement in self-efficacy, social limitation and physical
A
limitation (3.910, 2.163 and 1.230, respectively). In the FNTC group, there was a CS improvement
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of ≥6 in six domains (physical limitations, symptom frequency, self-efficacy, social limitations,

non-clinical summary and overall summary) and ≥5 in two domains (total symptoms and clinical
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summary). In the conventional care group, a CS of ≥6 occurred regarding symptom frequency,

whereas a level of ≥5 was reached within four domains (self-efficacy, social limitations, non-
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clinical summary and overall summary) (Table 4).

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3.4. Self-care behaviour and depression

There were no SS differences in EHFScB-9 scores within or between the groups. All patients scored
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below the predefined threshold of 25, indicating no signs of major depression; however, a SS

reduction in scores (p ≤ 0.01) was seen among all patients, with a non-significant interaction effect

of 1.169 in favour of the FNTC group (Table 4).

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4. Discussion and conclusion

4.1. Discussion

To our knowledge, this is the first large scale randomised multi-centre trial reporting short-term (3

months) outcomes in outpatients with HF after FNTC in addition to conventional care. We were

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unable to demonstrate any overall SS benefit of FNTCs on health-related quality of life. This is in

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line with a recent systematic review of randomised trials evaluating the effect of family-based

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education for patients with HF and their carers [58]. Health-related quality of life, self-care

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behaviours and depressive symptoms were assessed in two of the included studies [26, 59] showing

no effect at either 3- or 12-month follow-up.

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The clinically importance of the KCCQ summary measurement reflects patient’s experiences of
N
health-related quality of life and, is strongly associated with subsequent 1-year cardiovascular
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mortality and hospitalisation [60, 61]. An improvement of 9.8 in self-efficacy scores in the FNTC
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group can be considered a substantial change because self-efficacy and mental well-being are

significantly associated with self-reported self-care [62].

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When adapting a psycho-education model for HF patient-partner dyads, Ågren et al. [26] found a

significant difference in patients’ perceived control in favour of the intervention. Their results might
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be in line with the observed improvement of self-efficacy in our study because the underlying
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concept of self-efficacy is identical. Also, Stamp and colleagues [25] found that patient’s
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confidence (e.g. self-efficacy) and motivation for self-care were significantly improved by a family

partnership intervention, compared to patient-family education or usual care. In addition, Clark et

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al. found that interventions to promote psycho-social well-being of patients with HF were most

effective when self-efficacy was increased [63]. Thus, although health-related quality of life is

recommended as an important measurement for patient reported outcomes in heart failure [64],

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other outcomes such as self-efficacy [65, 66] or family functioning, family health and social support

might be more suitable to measure the benefit of psycho-social interventions.

There are some limitations to the trial. In total 121 (26%) patients were lost to follow-up, 10 due to

death. The dropout rate accounted for 4% more in the control group, but baseline characteristics of

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the remaining patients did not differ SS from those of the patients who completed the

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questionnaires, except to marriage and self-employment. Limited statistical power may be

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important, but, on the other hand, the differences in the primary outcome between the groups were

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very small, and the detection of a difference between overall summary scores of 72.9 and 73.2

would require approximately 173,638 patients if a type 2 error of 20% is accepted.

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The period of data collection lasted 5.5 years, which might have interfered with changes in the
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conventional treatment of the patients; however, no substantial changes between centres were
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observed during this period. In addition, the strengths of the randomisation and allocation processes
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used might also level out any changes.

It can be questioned whether the sample is representative of other patients with HF. Compared to
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the study by Ågren et al. [26], the patients in our study were somewhat younger (mean 67 years)
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and the majority were classified as NYHA II; while the mean age of patients in their study was 71

years and the majority were classified as NYHA III and IV. Three-quarters of the patients in both
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studies were men. Future studies should consider these diversities in age, gender and symptom
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burden.

In total 27% of the FNTCs were carried out with only the patient present. It is not unusual for
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patients to exclude family members from the support offered [67], therefore, this study reflects the

actual circumstances for implementation of FNTC in the routine care of outpatients with HF. Future

14
studies should consider whether the conversations should only be offered when family members are

present or which families might benefit the most from the intervention.

Thirty patients received the FNTC intervention without adequately responding to the questionnaire,

but remained in the intervention group in accordance with an intention-to-treat analysis, which

might also have limited the effect of the intervention. Also, it may have been too difficult for some

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of the patients in our study to complete the relatively high numbers of items included in the

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questionnaire package because 38% had 7 years or less basic school education and some may also

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have had cognitive impairment.

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Since the conversations were individualised to the specific needs of the patients it may be that

participants received different treatment which impacted the results. To account for this,

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future studies should audiotape/videotape and score the conversations, so that the components
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of the intervention can be accurately defined and standardised. In addition, patients and
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nurses were not blinded to the intervention, which may have influenced the care and
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behaviour of patients in the control group.

Finally, although the nurses were equally competent to deliver the FNTC, it cannot be ruled out that
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their competencies improved during the trial, and this might have limited the effect of the
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intervention.
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4.2. Conclusion
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In this multicentre trial, there were no SS differences in KCCQ summary score between groups

receiving FNTC or conventional care. Patients in the FNTC group reached a CS level of ≥6 in seven
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domains, with the highest improvement in self-efficacy, social limitation and symptom burden.

Patients who only received conventional care reached a CS level of ≥6 in one domain. In both

15
groups, there was a SS decline in symptom stability. There were no differences in self-care and

depression between the groups.

4.3. Practical implications

The study demonstrates that the care of patients in nurse-lead HF clinics can improve patients´

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health-related quality of life and subsequently reduce the risk of death and hospitalisation for HF

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[61]. This knowledge may be useful in the monitoring of the clinical status of individual patients

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with HF. Additionally focus on family relationships might further improve the CS of the care

SC
leading to even lower risk for cardiovascular death/readmissions. More well-designed multicentre

trials, including well-defined components of the intervention, with adjusted outcome measures,

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and careful considerations about who might benefit the most from the conversations, are needed to
N
confirm whether FNTC is an effective supplement to standard care of outpatients with HF.
A
M

Acknowledgements

We thank the patients, project nurses and student assistants for their contributions to this study.
ED

Funding
PT

The trial was supported by The Health Foundation (no. 2010B112), The Danish Heart Foundation
E

(no. 10-04-R79-A2785-22575), The Novo Nordisk Foundation (date 2010.11.11), The Research
CC

Council, Odense University Hospital (Journal no. 2-41-4-00064-2009) and Master Carpenter Alfred

Andersen and Wife’s Foundation (date 2010.05.31) – all not-for-profit organisations.

A

Conflicts of interest

None declared.

16
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E PT
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A

24
 Figure caption

Figure 1. Flow Diagram of patients assigned to Family Nursing Therapeutic

Conversations or conventional care

Enrollment 1478 Assessed for eligibility

T
Not eligible n = 1010

IP
 Not meeting inclusion criteria n=682
 Declined to participate n= 173
 Other reasons n= 155

R
SC
468 Randomized

Allocation U
N
 Allocated to FNTC + conventional care n = 232  Allocated to conventional care n = 236
A
 Project nurses’ performed the care n = 7  Specialized HF nurses’ performed the care
 Centers involved n = 3  Centers involved n = 3
M

Patients treated by each centre Patients treated by each centre

- Centre 1: n = 77 - Centre 1: n = 78
- Centre 2: n = 93 - Centre 2: n = 96
- Centre 3: n = 62 - Centre 3: n = 62
ED
PT

 Received FNTC n = 211 Received allocated intervention n= 202

 Did not receive FNTC n= 21  Did not receive conventional care n = 34
- Withdraw before baseline assessment n = 18 - Withdraw before baseline assessment
E

- Dead n = 3 n = 32
- Dead n = 2
CC

Follow-Up
A

Lost to follow-up n = 31 Lost to follow-up n = 35

- Declined to fulfil the questionnaire n = 29 - Declined to fulfil the questionnaire n = 32
- Dead n = 2 - Dead n = 3

Analysis
3 months’ follow-up n = 180 3 months’ follow-up n = 167

Excluded from analysis (give reasons) (n= )

25
Table 1. Content of the sessions used in the intervention

FNTC in addition to Conventional

Content conventional care care

Realisation of treatment plan for optimising pharmacologic treatment X X

Individual assessment of the need for expertise from other professionals X X

(cardiologist, dietitian, social worker, physiotherapist, psychologist,

T
psychiatrist)

IP
Individual information, supervision and education in accordance to evidence X X

R
based clinical guidelines

Delivery of booklet with individualised written material X X

SC
Individual telephone consultation X X

Drawing genogram, reflecting a picture of family structure and social X

relationships U
N
Encouraging patient/family member to tell their illness narrative and to X
A
reflect upon their beliefs about the heart failure diagnosis.
M

Asking patient/family member about their expectations regarding the X

meeting, and which issues and problems they consider most important
ED

Identification of goals for the future X

Conversations about the impact of the illness on the family unit as well as X
PT

the individual member’s daily lives

Circular questions focusing on commendations, strengths and resources X

E

within the family

CC

Evaluation of the intervention based on conversation, observation, goal X

setting and perceptions of the families

A

26
Table 2. Patient Characteristic

Baseline characteristics of Baseline characteristics of

randomised patients (n = 466)a patients lost to follow-up (n = 88)a

Variables Intervention Control Intervention Control

group group group group

Age, years, mean (SD) 66.6 (12.4) 66.9 (12.4) 66.8 (13.5) 66.5 (14.7)

T
Gender, male, n (%) 172 (36.9) 173 (37.1) 31 (35.2) 30 (34.1)

IP
NYHA classification, n (%)

NYHA II 186 (39.9) 188 (40.3) 37 (41.1) 37 (41.11)

R
NYHA III 46 (9.9) 45 (9.7) 5 (5.7) 9 (10.2)

SC
NYHA IV 1 (1.1)

LVEF, mean (SD) 27.6 (8.6) 27.3 (8.7) 27.4 (9.2) 25.8 (9.0)

Blood pressure, mm/Hg, mean (SD)

U
N
Systolic 127 (19.3) 127 (20.4) 129 (19.6) 129 (19.3)
A
Diastolic 76 (11.1) 77 (12.7) 75 (11.5) 78 (11.2)
M

BMI, mean (SD) 26.8 (5.5) 26.9 (5.7) 26.6 (5.3) 27.1 (6.6)

Duration of disease, months, mean (SD) 7.0 (20.2) 7.1 (20.1) 6.7 (20.3) 3.5 (14.4)
ED

Current smoker, n (%) 53 (11.5) 48 (10.4) 12 (14.1) 12 (14.1)

Comorbidity, n (%)*
PT

Diabetes 32 (6.9) 38 (8.2) 10 (11.4) 6 (6.8)

Hypertension 81 (17.4) 94 (20.2) 13 (14.8) 19 (21.6)

E

Stroke 26 (5.6) 19 (4.1) 3 (3.4) 4 (4.5)

CC

Atrial fibrillation 64 (13.7) 95 (20.4)b 11 (12.5) 17 (19.3)

Myocardial infarction 81 (17.4) 77 (16.6) 20 (22.7) 17 (19.3)

A

COPD 35 (7.5) 30 (6.4) 7 (8.0) 4 (4.5)

Medication, n (%)*

ACE-inhibitor 184 (39.6) 181 (38.9) 33 (37.5) 37 (40.0)

AT-II inhibitor 32 (6.9) 33 (7.1) 7 (8.0) 3 (3.4)

27
 Beta-blocker 190 (40.9) 192 (41.3) 35 (39.8) 35 (39.8)

Aldosterone antagonist 94 (20.3) 95 (20.5) 18 (20.5) 24 (27.3)

Diuretic 170 (36.6) 186 (40.0) 28 (31.8) 34 (38.6)

Digoxin 25 (5.4) 40 (8.6) 5 (5.7) 8 (9.1)

Antithrombotic 144 (31.0) 155 (33.3) 25 (28.4) 29 (33.0)

Antiarrhythmic 22 (4.7) 25 (5.4) 3 (3.4) 6 (6.8)

T
Antidepressant 23 (4.9) 23 (4.9) 9 (10.2) 5 (5.7)

IP
Matrimonial status n (%)*

Married 138 (29.6) 147 (31.5) 20 (22.7) 21 (23.9)

R
Cohabiting 19 (4.1) 17 (3.6) 3 (3.4) 4 (4.5)

SC
Divorced 37 (7.9) 25 (5.4) 9 (10.2) 10 (11.4)

Widower 31 (6.7) 31 (6.7) 4 (4.5) 9 (10.2)

Unmarried 24 (5.2) 25 (5.4)

U 7 (8.0) 7 (8.0)
N
Basic school n (%)*
A
7 years or less 85 (18.2) 94 (20.2) 10 (11.4) 21 (23.9)b
M

8 to 10 years 132 (28.3) 123 (26.4) 27 (31.0) 24 (27.3)

High school graduation 34 (7.3) 43 (9.2) 4 (4.5) 4 (4.5)

ED

Others 13 (2.8) 10 (2.2) 2 (2.3) 1 (1.2)

Education, n (%)*

None 49 (10.5) 51 (10.9) 11 (12.5) 12 (13.6)

PT

Vocational 109 (23.4) 125 (27.0) 13 (15.0) 14 (16.0)

Further education ≥ 3 years

E

80 (17.2) 67 (14.4) 13 (15.0) 8 (9.1)

CC

Work, n (%)*

Self-employed 35 (8.0) 31 (7.0) 51 (58.0) 56 (64.0)

Employee 93 (20.0) 100 (22.0) 16 (18.2) 13 (15.0)

A

Unemployed 10 (1.3) 6 (0.6) 1 (1.1) 2 (2.3)

Pensioner 127 (27.3) 130 (27.9) 20 (22.7) 25 (28.4)

a
Data missing for two patients; bp ≤0.05; NYHA=New York Heart Association Classification;
LVEF=Left Ventricle Ejection Fraction; BMI=Body Mass Index; COPD=Chronic Obstructive
Pulmonary Disease; *Variables could have multiple responses

28
Table 3. Demographic characteristics of family members (n = 322)

Variables FNTC intervention group Control group

(n = 162) (n = 160)

Age, mean (SD) 59.4 (15.3) 64.3 (31.9)

Gender, n (%)

T
IP
Female 128 (79.5) 126 (79.2)

Male 33 (20.5) 33 (20.8)

R
Marital status, n (%)*

SC
Married 113 (69.8) 128 (80.0)a

Cohabiting 24 (14.8)
U 15 (9.4)
N
Divorced 15 (9.3) 7 (4.4)
A
Widower 9 (5.6) 4 (2.5)
M

Single 20 (12.3) 14 (8.8)

Basic school, n (%)*

ED

7 years or less 35 (21.7) 37 (23.6)

8 to 9 years 31 (19.3) 30 (19.0)

PT

10 years 55 (34.2) 56 (35.4)

E

High school graduation 32 (19.9) 40 (25.3)

CC

Education, n (%)*

None 27 (16.9) 29 (18.4)

A

Apprentice 32 (20.0) 24 (15.2)

Other vocational 42 (26.3) 53 (33.5)

Advanced < 3 years 25 (15.6) 18 (11.4)

29
 Advanced 3 to 4 years 27 (16.9) 35 (22.2)

Advanced > 4 years 17 (10.6) 14 (8.9)

Work, n (%)*

Self-employed 11 (6.9) 10 (6.3)

Assisting spouse 11 (6.9) 4 (2.5)

T
Skilled worker 29 (18.2) 25 (15.7)

IP
Worker 16 (10.1) 20 (12.6)

R
Salaried employee 34 (21.4) 37 (23.3)

SC
Unemployed 1 (0.6) 8 (5.0)a

Pensioner 77 (48.4) 93 (58.5)

U
SD = Standard Deviation; ap = <0.05; *Variables could have multiple responses; FNTC = Family
N
Nursing Therapeutic Conversations
A
M
ED
E PT
CC
A

30
Table 4. Health-related quality of life, Self-care behaviour and depression scores of patients with
heart failure receiving conventional care or FNTC in addition to conventional care (n = 347)
FNTC in addition to FNTC
Conventional care (n =
conventional care (n = effecta
167)
180)

Scale Domain Baseline 3 months Baseline 3 months

T
75.3 (22.9) 80.2 (21.2) 74.6 (24.1) 80.8 1.230

IP
KCCQ Physical limitations
(20.4)**

R
65.7 (25.8) 61.7 (21.4) 65.9 (24.1) 59.6 -2.278

SC
Symptom stability
(22.7)**

68.2 (23.8) 74.7 69.3 (21.6) 75.5 -0.328

Symptom frequency
U
(21.0)** (19.2)**
N
71.7 (20.7) 74.6 (20.4) 71.0 (20.7) 75.6 1.709
A
Symptom burden
(20.1)**
M

68.2 (22.1) 74.0 (19.1)* 65.8 (23.7) 75.6 3.910

ED

Self-efficacy
(23.3)**

62.9 (26.7) 68.6 (26.6)* 62.6 (28.3) 70.4 2.163

PT

Social limitations
(24.8)**
E

Quality of life 62.9 (21.5) 68.4 (21.8) 61.4 (22.6) 66.5 (23.0) -0.326
CC

Total symptoms 69.9 (21.2) 74.7 (18.5) 70.1 (21.3) 75.5 19.0)* 0.690

Clinical summary 72.6 (19.2) 77.4 (18.8) 72.3 (19.4) 78.1 (17.5)* 1.029
A

Non-clinical 63.0 (21.7) 68.5 (22.1)* 62.1 (23.2) 68.1 0.546

summary (23.0)**

31
 67.8 (18.8) 72.9 (19.3)* 67.2 (19.6) 73.2 0.857
Overall summary
(19.0)**

Adherence to 4.3 (0.7) 4.3 (0.7) 4.1 (0.7) 4.1 (0.7) -0.044
EHFScB-9
regimen

Consulting 4.3 (1.0) 4.2 (1.0) 4.2 (1.1) 4.1 (1.0) -0.032

T
behaviour

IP
MDI Depression 16.5 (9.3) 14.4 (9.7) 16.0 (9.2) 15.1 (10.1) 1.169

R
Mean (SD); *Clinical significance, score ≥5; **Clinical significance, score ≥6

SC
FNTC = Family Nursing Therapeutic Conversations
KCCQ = Kansas City Cardiomyopathy Questionnaire

U
EHFScB-9 = European Heart Failure Self-care Behaviour 9-item Scale
N
MDI = Major Depression Inventory
a
A
FNTC effect = improvement of scores in the intervention group compared to control group
M
ED
E PT
CC
A

32