YJPDN-02200; No of Pages 8

Journal of Pediatric Nursing xxx (xxxx) xxx

Contents lists available at ScienceDirect

Journal of Pediatric Nursing

journal homepage: www.pediatricnursing.org

Effect of family empowerment education on pulmonary function and

quality of life of children with asthma and their parents in Tunisia: A
randomized controlled trial
Maha Dardouri, Ph.D ⁎, Jihene Sahli, M.D, Thouraya Ajmi, M. D, Ali Mtiraoui, M.D., Jihene Bouguila, M.D,
Chekib Zedini, M.D, Manel Mallouli, M.D
Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui,
4002 Sousse, Tunisie

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: Patient education is fundamental in asthma management, especially at pediatric age. It is increasingly
Received 20 December 2019 recognized as effective in reducing the burden of the disease, but is less clear in improving the quality of life of
Revised 6 April 2020 children with asthma and their parents. This study assessed the effect of an asthma therapeutic education pro-
Accepted 6 April 2020 gram on pulmonary function and quality of life in children with asthma and their parents.
Available online xxxx
Design and methods: A monocentric randomized controlled trial conducted in Farhat Hached University Hospital
of Sousse (Tunisia) from May 2018 to September 2019. Thirty-seven families in the experimental group and 39
Keywords:
Asthma
families in the control group received allocated intervention at baseline. Thirty-four families in each group com-
Child pleted the study at the 12-month follow-up.
Caregiver Results: The intervention significantly improved quality of life scores of children and their parents (all p b 0.05).
Nurse Children in the experimental group had significantly better forced expiratory maneuver than children in the con-
Empowerment trol group. Nonetheless, the FEV1/FVC ratio did not show any significant difference in the experimental and con-
trol group (p = 0.9; p = 0.14, respectively).
Conclusions: This study demonstrated that a long-term family-based asthma education program resulted in bet-
ter pulmonary function and QOL of children and parents enrolled in the intervention group, particularly children
with non-allergic asthma.
Practice implications: Family-based asthma education can reduce the burden of allergic and non-allergic asthma
on children and their parents through improving their quality of life. Also, the pulmonary function of children
with non-allergic asthma was improved due to My Asthma Therapeutic Education intervention.
© 2020 Elsevier Inc. All rights reserved.

Introduction
In recent years, the prevalence of asthma symptoms has globally in-
creased in children and adolescents, particularly in low-middle income
countries. Genetics and environmental factors (exposure to passive
smoking and air pollution), seemed to contribute to this trend
(Ferrante & La Grutta, 2018). According to estimations of the World
Health Organization, 80% of asthma-related deaths occurred in low-
middle income countries (World Health Organization, 2017). It still im-
poses an enormous clinical and social burden on patients and their fam-
ilies, even in a mild stage (Global Initiative for Asthma, 2019).
Symptoms such as cough, shortness of breath and activity intolerance,
as well as emotional problems such as fear of asthma exacerbation,
will affect the quality of life (QOL) of children with asthma (Al-
⁎ Corresponding author.
E-mail address: maha.dardouri@famso.u-sousse.tn (M. Dardouri).
Khateeb & Al Khateeb, 2015). Over the past decades, the concept of
QOL has become a major issue in the context of chronic diseases, and
a primary outcome in clinical trials (Baiardini et al., 2010; Mallouli
et al., 2017). It is often used to describe the effect of asthma on the
child's daily life and well-being. Hence, its evaluation becomes
compulsory when judging the effectiveness of clinical interventions
(Montalbano et al., 2019). Additionally, the social burden of asthma
for parents is considerable. It was demonstrated that having a child
with chronic illness, such as asthma, may be a hard challenge for parents
(Svavarsdottir & Rayens, 2005). They experience daily life limitations,
anxiety and emotional stress due to their child's asthma (Al-Akour &
Khader, 2009). Therefore, it is substantial to assess the QOL of the parent
as the primary caregiver (Ferrante & La Grutta, 2018).
Since asthma is a variable condition that often remains uncontrolled,
resulting in frequent acute healthcare use and impaired QOL, patients'
involvement in the management of their condition helps improve its
control (Boulet, 2015). According to the WHO, the integral management

https://doi.org/10.1016/j.pedn.2020.04.005
0882-5963/© 2020 Elsevier Inc. All rights reserved.

Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
2 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx

of this disease should set out to control the symptoms, keep up normal
lung function, and prevent future complications (World Health
Organization, 2017). In their study, Juniper and colleagues demon-
strated that in children, change in both physiological measures and
asthma control were more closely related to parents' rather than to
children's global rating of change in symptoms (Juniper, 1997). Accord-
ing to Piaget's theory, school-aged children gain the ability to solve con-
crete problems. This allows them to manage and control asthma by
themselves and with parents' supervision through education and sup-
port. Hence, growing evidence supports family empowerment since it
is the cornerstone of the philosophy of family-based care. Indeed, family
empowerment education gives families the ability to reduce stress, im-
prove self-esteem, reinforce welfare and promote the families' well-
being. Educating groups of families regarding control of symptoms, pre-
vent triggers, controller adherence and how to act effectively in case of
an asthma exacerbation can facilitate family empowerment.
A previous randomized controlled trial also confirmed that family
empowerment program decreased parental stress and increased family
function and lung function of children with asthma (Yeh, Ma, Huang,
Hsueh, & Chiang, 2016). Additionally, two quasi-experimental studies
confirmed that family empowerment programs improved the QOL of
children with asthma and the QOL of their parents (Fouda, El-zeftawy,
Mohammed, & Mohammed, 2015; Payrovee, Kashaninia, Mahdaviani,
& Rezasoltani, 2014).
The allergic condition is known to play an important role in asthma.
Clinical trials that evaluate the effect of family empowerment education
on asthma outcomes by asthma phenotypes have not been performed
so far.
Added to that, studies regarding asthma education programs in low-
and lower-middle-income countries are limited (Mosnaim, Akkoyun,
Eng, & Shalowitz, 2017). This study was designed to evaluate the effect
of a family empowerment education program on the QOL of children
and their parents as primary outcomes and on the child's pulmonary
function as a secondary outcome among children with asthma accord-
ing to their asthma phenotypes.
The hypothesis of this study was that the education program that
combines a family empowerment program with usual care education
could improve primary and secondary outcomes in children with aller-
gic and non-allergic asthma in comparison to usual care education only.
This improvement was predicted to be maintained at the 12-month
follow-up for the experimental group.
Methods
Study design
This monocentral study employed a randomized controlled trial
(RCT) design. It took place in the pediatric outpatient clinic of Farhat
Hached University Hospital in Sousse, Tunisia, over a 17-month period.
This hospital is the main pediatric asthma care center in the center of
Tunisia. Measurements of pulmonary function and QOL of children
and QOL of parents were performed at baseline and follow-up. The

Fig. 1. CONSORT flow diagram of participants’ recruitment. ⁎ MyATE: My Asthma Therapeutic Education (Family Empowerment Education Program+ IEAS). ⁎⁎ IEAS: Individual Education
by Asthma Specialist.

Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx
study started in May 2018 and ended in September 2019. The interven-
tion program lasted for 14 months and included four educational ses-
sions over eight weeks (July–August 2018) and 12-month follow-up
after the end of the intervention.
Participants
Families of children with asthma referred to the pediatric outpatient
clinic of Farhat Hached University Hospital were assessed for eligibility.
Inclusion criteria included the following: 1) children aged 7 to 17 years,
2) fulfilled the Global Initiative for Asthma diagnostic criteria for asthma
of confirmed variable expiratory airflow limitation documented from
bronchodilator reversibility testing and history of variable respiratory
symptoms at least 12 months before the study period, 3) mild to severe
asthma, 4) telephone availability, 5) ability to fill out the questionnaire
in Arabic, and 6) the presence of the parent. Exclusion criteria were the
presence of specific physical or mental disease, confirmed diagnosis of
another lung disease, and the participation in another experimental
study.
Study groups and intervention
A total of 82 eligible children with asthma and their parents were
randomly assigned to experimental or control group using sealed
opaque envelopes. Parents signed an informed consent and children
were asked for their permission before randomization. Because of short-
age of time and unwilligness of the parents to participate in the study,
four families in the intervention group and two families in the control
group did not receive allocated intervention. A total of 37 families in
the intervention group received “My Asthma Therapeutic Education
(MyATE)”, which couples a Family Empowerment Education Program
and Individual Education by Asthma Specialist (IEAS). The control
group (39 families) received only IEAS.
IEAS is the usual care education demonstrated by a regular 5 min of
asthma education by the asthma specialist at the end of the patient's
consultation. Four families in the intervention group chose not to com-
plete the questionnaires at baseline and did not receive the allocated in-
tervention. Three families (2 boys and 1 girl) in the intervention group
and five families (4 boys and 1 girl) in the control group dropped out
for various reasons (not able to be contacted, parent believed the child
no longer had asthma, no longer want to continue the study). The age,
gender, monthly family income, past asthma education and asthma se-
verity in the dropouts did not influence the homogeneity of baseline
characteristics between the intervention and control group. At last, 34
families completed the study in each group (Fig. 1).
The content of the family empowerment program was prepared by
the principal researcher, and revised by the pediatrician-pulmonologist.
It was designed to help improve the child's pulmonary function as well
as children and parents' QOL. The sessions' topics included basic informa-
tion about asthma, recognition and response to asthma symptoms and
asthma exacerbations, use of asthma medication and inhalation tech-
nique, identification and control of asthma triggers, as well as effective
ways to communicate with health care providers. The intervention took
place in the waiting room of the pediatric outpatient clinic of the univer-
sity hospital. It was composed of four group sessions divided into two
days over eight weeks.
During the intervention and follow-up periods, families in the inter-
vention group were in touch with the researcher via telephone in order
to discuss any faced problems. An asthma booklet and an action plan for
asthma crisis based on the Global Initiative for Asthma guidelines in the
native language of the participants was provided (Global Initiative for
Asthma, 2019). The booklet of asthma education was designed by the
principal researcher and reviewed by the pediatrician. It covered most
of information related to child asthma care simply and clearly. The con-
trol group was trained after the collection of follow-up data.
Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
3
Instruments
The QOL of children and parents were the primary outcomes of this
study. The Arabic version of the Pediatric Asthma Quality of life Ques-
tionnaire (PAQLQ) was used to assess the QOL of children aged 7 to
17 years (Al-Akour & Khader, 2008). This instrument is available in 77
languages including Arabic, which was produced by the authors of the
questionnaire. Cultural adaptation and linguistic validation have been
done by the MAPI Research Institute, Lyon, France (Acquadro, Conway,
Giroudet, & Mear, 2004). All versions of the PAQLQ have strong mea-
surement properties and have been fully validated for use in both clin-
ical practice and clinical trials (Juniper, Guyatt, Feeny, Griffith, &
Ferrie, 1997; Raat et al., 2005). They have good discriminative proper-
ties (reliability and cross-sectional validity). The PAQLQ contains 23
items in three domains: symptoms (consisting of 10 items, including
shortness of breath, wheeze, cough, tightness of chest, and tiredness),
emotional function (consisting of 8 items, including frustration, fear,
anxiety, anger, and feeling different and left out), and activity limita-
tions (consisting of 5 items, including physical, social, school, and
sleeping). Children were asked to recall their experiences during the
previous week and to respond to each question on 7-point scale (1 =
extremely bothered, 2 = very bothered, 3 = quite bothered… 7 =
not bothered) (Juniper, 1997; Juniper, Guyatt, Feeny, Griffith, & Ferrie,
1997). The overall PAQLQ score is the mean of the responses to each
of the 23 questions. It was calculated by adding all of the 23 responses
together and dividing by 23. The resultant overall score was between
1 and 7 (1 = severe impairment, 4 = moderate impairment, 7 = no im-
pairment,). The domains were analyzed in exactly the same way.
The Arabic version of the Pediatric Asthma Caregiver Quality of
life Questionnaire (PAQLQ) was used to assess the QOL of parents
of children with asthma. The PACQLQ estimates the parent's daily
life impairment related to the child's asthma disease during the pre-
vious week. It contains 13 items divided into two domains, activity
limitations and emotional function. The activity limitations domain
shows the extent to which the parents are restricted because of
asthma (4 items including work interference and sleepless nights
because of the child's asthma). The emotional domain reports the
feelings and emotional problems of the parents due to asthma (9
items including feeling impatient, upset and angry because of
asthma). Parents are asked to recall their experiences during the pre-
vious week and to score impairment on a 7-point scale. The PACQLQ
and its domains scoring method is exactly the same as the PAQLQ.
The overall score is the mean of the responses to all 13 questions
(Al-Akour & Khader, 2009).
Pulmonary function was assessed by spirometry test using ZAN 100
according to the national spirometry reference values in children
(Trabelsi et al., 2004). Spirometry measures included FEV1, forced
vital capacity (FVC), and FEV1/FVC. The calibration of the spirometer
was performed every day before the first test. The respiratory nurse ex-
plained and demonstrated breathing maneuvers to children: Normal
breathing (3 to 5 regular breaths) followed by maximal inspiration
then forced and prolonged exhalation. Three maneuvers with a maxi-
mum of 5% variability were registered according to international
standards.
The demographic data of the families were parent-reported. They in-
cluded age, gender, the severity of asthma, duration of asthma, past
asthma education and asthma phenotype, first caregiver, his/her age, ed-
ucational level, monthly family income, health insurance, past asthma
education.
Monthly family income was classified according to the minimum
wage in the country of the study, which was equal to USD 537.72 in
2018 (National Institute of Statistics, 2018). Low monthly income was
considered equal to or less than the minimum wage. Middle monthly
income was considered one to three times the minimum wage and
high monthly income was considered greater than three times mini-
mum wage.
4 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx

Sample size calculation Table 1

Demographic and clinical characteristics of children with asthma at baseline by groups.

The minimum clinically significant difference (Minimal Important Variables MyATE (n = 34) IEAS (n = 34) X2 p
Difference) in the total QOL score in the PAQLQ and the PACQLQ is
Age
close to 0.5 points on the 7-point scale (Juniper et al., 1997). According 7–12 y 26 28 0.360 0.38
to previous studies, a conventional medium effect size of 0.5 was se- ≥13 y 8 6
lected in the variations of pulmonary function (Tzeng, Chiang, Hsueh,
Gender
Ma, & Fu, 2010; Yeh et al., 2016). Based on those figures, a calculated Female 18 14 0.944 0.23
sample size with a power 1 – β = 0.8, and two-tail α = 0.05 using Male 16 20
the G*Power (3.1.9.4) was performed. This calculation pointed to a
Family monthly income
total of 55 participants. Since families of children with asthma could Low 8 12 1.133 0.21
dropout, that number was increased by 20% (66 participants and 33 Middle-high 26 22
per group).
Insurance
No 18 18 10 ̵ 3 0.59
Data analysis Yes 16 16

First caregiver
Data analysis was performed according to the study aim using the Mother 33 31 1.063 0.30
Statistical Package of Social Science software (SPSS) version 20.0 for Father 1 3
Windows. Continuous variables were described as means ± Standard Age of FCG ͣ
Deviations (SD). The normal distribution of continuous variables was 29–39 y 21 21 10 ̵ 3 0.37
checked using the Kolmogorov-Smirnov test. Categorical variables ≥ 40 y 13 13
were described as frequencies and percentages. Data were analyzed FCG's educational level
based on the total number of non-missing cases (n = 68). To analyze Illiterate-Primary 15 12 0.553 0.31
demographic differences between the experimental and control group Secondary-University 19 22
at baseline, the Chi-square test was applied. Independent t-test and FCG's past asthma education
paired t-test were performed as required to investigate the differences No 25 30 2.37 0.1
between groups and within time. All findings were presented with Yes 9 4
95% confidence intervals (95% CI). Based on two-tail tests, a p-value Child's past asthma education
b0.05 was considered statistically significant. No 27 31 1.876 0.15
Yes 7 3

Ethical considerations Family history of asthma

No 21 24 0.591 0.3
Yes 13 10
The study was approved by the research ethics committee of the
University of Sousse-Faculty of Medicine of Sousse. It was retrospec- Smoking exposure
tively registered with the Pan African Clinical Trial Registry. The permis- No 18 21 0.541 0.31
Yes 16 13
sion of Professor Juniper was obtained to use the Arabic version of the
PAQLQ and the PACQLQ (Al-Akour & Khader, 2008, 2009). The package Severity of asthma
of the questionnaires was received by airmail. Parents were given a let- Mild 24 22 0.269 0.39
Moderate 10 12
ter explaining all of the details regarding the study and emphasizing the
voluntary nature of their participation, plus informing them that they Phenotypes of Asthma
have the right to discontinue participation in the study at any time, Allergic asthma 15 25 6.071 0.01
Non-allergic asthma 19 9
and for any reason, following the Declaration of Helsinki. In addition,
an informing letter in “story form” was read to children. All parents Use of anti-allergic medication (n = 40)
signed informed consent and children were asked for their permission No 11 15 0.733 0.39
before participation. All of the obtained data were considered as confi- Yes 4 10

dential and anonymous. Data were analyzed based on the total number of non-missing cases (n = 68); aFCG: First
caregiver.

Results
Table 1 shows the demographic and clinical data of the participants
at baseline. There were no statistically significant differences between
the experimental and the control groups in terms of clinical and demo-
graphic characteristics.
Individuals lost to follow-up
The attrition rate was 10% and did not significantly differ between
the two groups (MyATE n = 3, IEAS n = 5) (Fig. 1). Missing data repre-
sented 4.5% and complete data were 95.5%. All the participants lost to
follow-up had mild asthma and non-allergic phenotype. Besides, nei-
ther parents nor children had past asthma education. There was no sta-
tistically significant difference between the participants and the
dropouts in terms of sociodemographic factors.
Primary and secondary outcomes comparisons in MyATE and IEAS at
baseline and follow-up.
Table 2 shows the total and subscale scores of the QOL question-
naires and the pulmonary function in both groups and within time.
The findings demonstrated that PAQLQ and PACQLQ total and subscale
scores (all p = 10 ̵ 3), as well as FVC (p = 0.04) in the MyATE group at
baseline and follow-up, were significantly and positively different.
However, in the control group, the total score of the PAQLQ and symp-
toms domain, as well as the activity limitations domain of the PACQLQ
showed a positive significance within time (p = 0.02; p = 0.005; p =
0.005, respectively).
Regarding the difference between groups, no significant difference
was found between the two groups at baseline, except the activity lim-
itations domain of the PAQLQ (p = 0.04). Nevertheless, significant dif-
ferences were noted between the two groups in primary (all p b 0.01)
and secondary outcomes (all p b 0.05) after the intervention, except
for the activity limitations domain of the PACQLQ (p = 0.06).
Table 3 shows the mean difference within time of the total and sub-
scale scores of the PAQLQ and the PACQLQ in both groups. Differences

Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx 5

Table 2
Comparison of the mean and SD of primary and secondary outcomes between the two groups at baseline and at 12-month follow-up.

Outcomes Group MyATE (n = 34) IEAS (n = 34) p-value

Time m (SD) m (SD)

PAQLQ ͣ
Total B† 4.50 (1.23) 4.87 (1.26) 0.22
F†† 6.29 (0.78) 5.39 (1.10) 10 ̵ 3
p-value 10 ̵ 3 0.02
Activity limitation B 3.88 (1.18) 4.51 (1.34) 0.04
F 5.89 (1.28) 5.01 (1.41) 0.01
p-value 10 ̵ 3 0.05
Symptoms B 4.59 (1.30) 4.98 (1.25) 0.21
F 6.41 (0.71) 5.66 (1.07) 0.001
p-value 10 ̵ 3 0.005
Emotional function B 4.78 (1.42) 4.97 (1.44) 0.59
F 6.39 (0.7) 5.26 (1.26) 10 ̵ 3
p-value 10 ̵ 3 0.26
PACQLQ ᵇ
Total B 4.08 (1.28) 3.98 (1.19) 0.72
F 5.27 (1.48) 4.41 (1.23) 0.01
p-value 10 ̵ 3 0.09
Activity limitation B 3.94 (1.54) 3.54 (1.29) 0.24
F 5.30 (1.79) 4.52 (1.70) 0.06
p-value 10 ̵ 3 0.005
Emotional function B 4.15 (1.33) 4.17 (1.31) 0.93
F 5.26 (1.43) 4.35 (1.09) 0.005
p-value 10 ̵ 3 0.49
Pulmonary function
FVC ͨ % predicted B 95.06 (16.36) 91.5 (19.68) 0.42
F 102.44 (18.46) 92.38 (16.76) 0.02
p-value 0.04 0.73
FEV1ᵈ % predicted B 93.26 (19.19) 86.82 (22.88) 0.21
F 99.32 (20.81) 85.08 (19.29) 0.005
p-value 0.07 0.49
FEV1/FVC % predicted B 85.62 (9.83) 81.85 (11.61) 0.15
F 85.50 (9.18) 80.08 (11.42) 0.03
p-value 0.9 0.14

Data were analyzed based on the total number of non-missing cases (n = 68).
ͣ PAQLQ: Pediatric Asthma Quality of Life Questionnaire, ᵇ PACQLQ: Pediatric Asthma Caregiver Quality of Life Questionnaire, ͨ FVC: forced vital capacity, ᵈ Forced expiratory volume in 1 s.
†B: Baseline, ††F: follow-up.

are calculated separately for each group. There were significant differ-
ences in the mean subtraction at baseline and follow-up between the
two groups in total and subscale scores of both questionnaires (all
p b 0.05), except for the activity limitations domain of PACQLQ (p = 0.37).
Primary and secondary outcomes comparison in MyATE and IEAS at base-
line and follow-up by asthma phenotypes
Table 4 shows the primary and secondary outcomes by asthma phe-
notypes in both groups and within time. In the experimental group,
children with allergic and non-allergic asthma and their parents demon-
strated a statistically significant improvement over time of all QOL scores
(Allergic asthma, respectively PAQLQ and PACQLQ: p = 10 3̵ ; p = 0.001;
Non-allergic asthma, respectively PAQLQ and PACQLQ: p = 10 ̵3; p =
0.003). Nonetheless, FVC was significantly different within time only in
children with non-allergic asthma (p = 0.02). This significance was pos-
itive as it indicated an improvement in the FVC score.
In children with allergic asthma in the control group, no significant
differences were reported in both primary and secondary outcomes at
baseline and follow-up, except for activity limitations of PACQLQ
(p = 0.02). However, significant differences within time were found
in children with non-allergic asthma in the control group in terms of
PAQLQ total score (p = 0.006), activity limitations (p = 0.001), symp-
toms (p = 0.002), FVC (p = 0.04), and FEV1 (p = 0.04).
In regards to participants with allergic asthma at baseline, there
were no statistically significant differences between the two groups,

Table 3
Average difference of total and subscale scores of the PAQLQ and the PACQLQ at baseline and follow-up in both groups.

Group MyATE (n = 34) IEAS (n = 34) p-value

Outcomes m (SD) m (SD)

PAQLQ ͣ
Total 1.74 (1.37) 0.58 (1.23) 10 ̵ 3
Activity limitation 1.95 (1.67) 0.55 (1.50) 10 ̵ 3
Symptoms 1.79 (1.51) 0.79 (1.30) 0.003
Emotional function 1.54 (1.41) 0.32 (1.49) 10–3

PACQLQ ᵇ
Total 1.30 (1.43) 0.39 (1.62) 0.01
Activity limitation 1.47 (1.67) 1.19 (2) 0.37
Emotional function 1.23 (1.51) 0.02 (1.74) 0.002

Data were analyzed based on the total number of non-missing cases (n = 68).
ͣ PAQLQ: Pediatric Asthma Quality of Life Questionnaire, ᵇ PACQLQ: Pediatric Asthma Caregiver Quality of Life Questionnaire.

Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
6 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx

Table 4
Primary and secondary outcomes by asthma phenotypes in both groups at baseline and at 12-month follow-up.

Allergic asthma Non-allergic asthma

Outcomes Group MyATE (n = 15) IEAS (n = 25) p-value MyATE (n = 19) IEAS (n = 9) p-value

Time m (SD) m (SD) m (SD) m (SD)

PAQLQ ͣ
Total B† 4.34 (1.28) 5.10 (1.13) 0.05 4.64 (1.20) 4.23 (1.44) 0.43
F†† 6.03 (0.81) 5.23 (1.20) 0.02 6.5 (0.72) 5.86 (0.53) 0.02
p-value 10 ̵ 3 0.55 10 ̵ 3 0.006
Activity limitation B 3.65 (1.32) 4.74 (1.26) 0.01 4.07 (1.06) 3.88 (1.44) 0.7
F 5.57 (1.44) 4.85 (1.54) 0.15 6.14 (1.12) 5.46 (0.91) 0.12
p-value 0.001 0.69 10 ̵ 3 0.001
Symptoms B 4.41 (1.23) 5.26 (1.08) 0.02 4.74 (1.37) 4.1 (1.39) 0.34
F 6.18 (0.77) 5.48 (1.18) 0.04 6.58 (0.63) 6.16 (0.44) 0.08
p-value 10 ̵ 3 0.29 10 ̵ 3 0.002
Emotional function B 4.68 (1.47) 5.14 (1.36) 0.32 4.86 (1.41) 4.48 (1.63) 0.53
F 6.12 (0.63) 5.09 (1.36) 0.003 6.61 (0.69) 5.73 (0.8) 0.006
p-value 0.002 0.84 10 ̵ 3 0.06

PACQLQ ᵇ
Total B 3.96 (1.31) 4.02 (1.15) 0.89 4.18 (1.29) 3.87 (1.36) 0.56
F 5.07 (1.35) 4.38 (1.34) 0.12 5.43 (1.59) 4.52 (0.87) 0.12
p-value 0.001 0.25 0.003 0.19
Activity limitation B 3.93 (1.49) 3.47 (1.22) 0.29 3.96 (1.61) 3.75 (1.52) 0.74
F 5.21 (1.85) 4.42 (1.75) 0.18 5.38 (1.78) 4.8 (1.63) 0.42
p-value 0.004 0.02 0.002 0.09
Emotional function B 3.98 (1.36) 4.26 (1.26) 0.51 4.28 (1.33) 3.92 (1.47) 0.53
F 5 (1.24) 4.34 (1.21) 0.10 5.46 (1.57) 4.39 (0.68) 0.02
p-value 0.002 0.80 0.008 0.37

Pulmonary function
FVC ͨ % predicted B 95.07 (16.33) 94.92 (20.68) 0.98 95.05 (16.83) 82 (13.29) 0.05
F 97.66 (18.15) 92.84 (16.07) 0.38 106.21 (18.29) 91.11 (19.52) 0.05
p-value 0.64 0.49 0.02 0.04
FEV1 ᵈ % predicted B 94.07 (17.94) 90.12 (24.04) 0.58 92.63 (20.58) 77.67 (17.24) 0.07
F 96.60 (17.34) 85.12 (19.34) 0.06 101.47 (23.43) 85 (20.30) 0.08
p-value 0.61 0.10 0.05 0.04
FEV1/FVC% predicted B 87 (8.04) 81.12 (10.92) 0.07 84.53 (11.13) 83.89 (13.85) 0.89
F 87.80 (6.51) 79.40 (12.56) 0.009 83.68 (10.66) 82 (7.68) 0.67
p-value 0.77 0.21 0.73 0.48

Data were analyzed based on the total number of non-missing cases (n = 68). aPAQLQ: Pediatric Asthma Quality of Life Questionnaire. ᵇPACQLQ: Pediatric Asthma Caregiver Quality of Life
Questionnaire. cFVC: forced vital capacity. ᵈForced expiratory volume in 1 s. †B: Baseline, ††F: follow-up.

except for activity limitations and symptoms domains of the PAQLQ
(p = 0.01; p = 0.02, respectively). At follow-up, significant differences
existed between the two groups in the total score of the PAQLQ, symp-
toms and emotional function domains, as well as the FEV1/FVC ratio
(p = 0.02; p = 0.04; p = 0.003; p = 0.009, respectively).
Regarding participants with non-allergic asthma at baseline, there
were no significant differences between the two groups in terms of pri-
mary and secondary outcomes. At follow-up, significant differences
were noted between the two groups in terms of emotional function do-
main and total score of the PAQLQ, and emotional function domain of
the PACQLQ (p = 0.006; p = 0.02; p = 0.02, respectively).
Table 5 shows the mean subtraction within the time of total and sub-
scale scores of the QOL questionnaires by asthma phenotypes in both
groups. In participants with allergic asthma, there were significant dif-
ferences in the mean subtraction between the two groups in total and
subscale scores of both QOL questionnaires (all p b 0.05), except for
total score and activity limitations domain of the PACQLQ (p = 0.1;
p = 0.57, respectively). Besides, the mean difference of QOL scores
was higher in the intervention group than in the control group.
Nevertheless, in children with non-allergic asthma, there was no sig-
nificant difference in the mean subtraction between the two groups in
total and subscale scores of both questionnaires.
Discussion
Patient education is a foundation of asthma care that can help to
achieve competency in understanding the disease and its treatment as
well as improved health status (Montalbano et al., 2019). In pediatric
asthma, strong child-parent-nurse communication is crucial for positive
asthma outcomes (Cicutto, Gleason, & Szefler, 2014). In this study,
MyATE, a long-term program that focuses on strengthening child-
parent-nurse connection through family empowerment and effective
communication with healthcare providers, was developed. Previous re-
search found that long-term education reduced asthma morbidity and
improved asthma knowledge in children with asthma (Guarnaccia
et al., 2018). Scant information is available on the impact of long-term
asthma education on the QOL of children and their parents. The results
of this study revealed that MyATE significantly increased spirometry pa-
rameters and QOL scores in children and their parents in comparison to
IEAS. This improvement remained at the 12-month follow-up.
Few studies, particularly randomized controlled trials, evaluated the
effect of asthma education on QOL of children with asthma and their
parents (Julian et al., 2015; Margellos-Anast, Gutierrez, & Whitman,
2012). Other randomized trials investigated short-term programs,
such as Roaring Adventures of Puff, self-care education, family empower-
ment, multidisciplinary and m-health education, on QOL of children
with asthma (Burkhart, Rayens, & Oakley, 2012; McGhan et al., 2010;
Montalbano et al., 2019; Mosenzadeh, Ahmadipour, Mardani,
Ebrahimzadeh, & Shahkarami, 2019; Payrovee et al., 2014). The above-
mentioned studies showed improvement of QOL scores among children
who received the intervention.
The current findings added to evidence that family-based education
could result in greater lung function and QOL scores in children with
asthma and their parents than individual education (Payrovee et al.,
2014; Yeh et al., 2016). Interestingly, these data showed improvement
over time in total score of the PAQLQ as well as the activity limitations

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 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx 7

Table 5
Average difference of total and subscale scores of the PAQLQ and the PACQLQ at baseline and follow-up by asthma phenotypes in both groups.

Allergic asthma Non-allergic asthma

Outcomes MyATE (n = 15) IEAS (n = 25) p-value MyATE (n = 19) IEAS (n = 9) p-value

m (SD) m (SD) m (SD) m (SD)

PAQLQ ͣ
Total 1.68 (1.42) 0.12 (1.01) 10 ̵ 3 1.86 (1.21) 1.63 (1.32) 0.65
Activity 1.92 (1.81) 0.11 (1.40) 0.002 2.07 (1.38) 1.57 (0.91) 0.34
limitation 1.77 (1.48) 0.22 (1.01) 1.84 (1.35) 1.96 (1.32) 0.82
Symptoms 1.44 (1.43) 0.05 (1.28) 0.002 1.74 (1.39) 1.25 (1.76) 0.42

Emotional
function 1.10 (0.96) 0.36 (1.55) 0.005 1.25 (1.61) 0.64 (1.39) 0.34
PACQLQ ᵇ 1.28 (1.46) 0.95 (1.98) 1.42 (1.75) 1.05 (1.64) 0.60
Total 1.02 (1.03) 0.07 (1.53) 0.09 1.18 (1.73) 0.46 (1.49) 0.3
Activity limitation 0.54
Emotional function 0.03

Data were analyzed based on the total number of non-missing cases (n = 68). aPAQLQ: Pediatric Asthma Quality of Life Questionnaire. bPACQLQ: Pediatric Asthma Caregiver Quality of Life
Questionnaire.

domains in children and parents in the comparison group, which high-
light the substantial but limited benefit of IEAS. Notably, the improve-
ment of lung function and QOL scores were significantly more
conspicuous in children and their parents who received MyATE than
in those receiving only IEAS. According to Juniper et al., the mean differ-
ence of QOL score among children in MyATE indicated large changes
(Juniper et al., 1997). Added to that, the mean difference among parents
represented a moderate change.
What this study adds is the significant improvement in QOL scores of
parents and children in the MyATE group, regardless of their asthma phe-
notype, which demonstrate the benefit from MyATE in reducing the bur-
den of allergic asthma on participants' QOL. Additionally, MyATE group
reported significantly a large to moderate change in QOL scores, regard-
less of their asthma phenotype. Nevertheless, participants with allergic
asthma enrolled in the IEAS group did not show a significant improve-
ment in primary outcomes. On the other hand, children with non-
allergic asthma in the control group showed significant improvement in
all domains and total score of QOL. This may be related to time effect
and non-allergic asthma discharge. Regarding pulmonary function, signif-
icant improvement over time in FVC was noted in all children with non-
allergic asthma, regardless of their participation in the intervention. How-
ever, children with allergic asthma in both groups reported no significant
difference. Nevertheless, the focus was on preventing asthma triggers and
improving treatment adherence including allergy medication in the
MyATE program. These findings could probably be due to the fact that
65% of children with allergic asthma did not use anti-allergic medication
at baseline. Another factor that may have contributed to these findings
is the high cost of allergy medication, especially immunotherapy. These
data suggest that training and education result in greater lung function
and QOL scores in children with non-allergic asthma. Hence, potential at-
tention should be given to children with allergic asthma through special
training programs. Yeh et al. (2016), in a randomized controlled trial eval-
uating the effectiveness of family empowerment on pulmonary function
among school-aged children with asthma, demonstrated that the inter-
vention led to increased FEV1 in comparison to the control group. Simi-
larly, Montalbano et al. (2019) in their randomized trial showed that
multidisciplinary therapeutic education combined with m-health led to
better performance of forced expiratory maneuvers. The significant con-
tribution of this study demonstrates that a long-term family-based
asthma education program that connects the child-parent-nurse led to
better QOL and pulmonary function in all children and parents of the in-
tervention group, particularly children with non-allergic asthma. How-
ever, the present study presented some limitations. First, double-
blinding was not possible. An objective measurement like spirometry
and Professor Juniper's questionnaires were used. Second, long-term pro-
spective studies often show an important dropout rate, which was the
case. Lastly, since this study was monocentric, the results are not general-
izable. Nevertheless, monocentric studies conserve the homogeneity of
the sample.
Application to practice
Even though this educational model did not fit all children with
asthma, it is believed that establishing a training program involving a
strong connection between the child, the parent, and the nurse is crucial
for reducing QOL alteration and enhancing asthma outcomes. Lastly,
this intervention could be adopted by public health policymakers and
pediatric nurses as an integral part of pediatric asthma care. Further-
more, it puts forward future specific interventions for children with al-
lergic asthma, which aims to improve pulmonary function.
Conclusion
Asthma is a common respiratory condition in children that still im-
poses a substantial burden on children and their families. Children
with asthma may be able to manage their condition more effectively
by raising awareness about the burden of asthma and focusing on
family-based asthma education. This study demonstrated that a long-
term family-based asthma education program resulted in better QOL
and pulmonary function in all children and parents enrolled in the inter-
vention group, particularly children with non-allergic asthma. These
findings suggested that a potential attention should be given to children
with allergic asthma through special training programs.
Funding
This research did not receive any specific grant from funding agen-
cies in the public, commercial, or not-for-profit sectors.
CRediT authorship contribution statement
Maha Dardouri: Conceptualization, Methodology, Software, Data
curation, Writing - original draft, Writing - review & editing. Jihene
Sahli: Conceptualization, Methodology, Software, Writing - review &
editing. Thouraya Ajmi: Visualization, Investigation. Ali Mtiraoui: Visu-
alization, Investigation. Jihene Bouguila: Supervision. Chekib Zedini:
Software, Validation. Manel Mallouli: Supervision.
Declaration of competing interest
The authors report no conflicts of interest.

Please cite this article as: M. Dardouri, J. Sahli, T. Ajmi, et al., Effect of family empowerment education on pulmonary function and quality of life of
children with as..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2020.04.005
8 M. Dardouri et al. / Journal of Pediatric Nursing xxx (xxxx) xxx
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