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Cardiac risk factors and prevention

Cardiac rehabilitation using the Family-


Centered Empowerment Model versus
home-based cardiac rehabilitation
in patients with myocardial infarction:
a randomised controlled trial
Amir Vahedian-Azimi,1 Andrew C Miller,2,3 Mohammadreza Hajiesmaieli,4
Mari Kangasniemi,5 Fatemah Alhani,6 Hosseinali Jelvehmoghaddam,7
Mohammad Fathi,4 Behrooz Farzanegan,8 Seyed H Ardehali,9 Sevak Hatamian,10
Mehdi Gahremani,4 Seyed M M Mosavinasab,1 Zohreh Rostami,11
Seyed J Madani,12 Morteza Izadi13

To cite: Vahedian-Azimi A, ABSTRACT


Miller AC, Hajiesmaieli M, KEY QUESTIONS
Objective: To determine if a hybrid cardiac
et al. Cardiac rehabilitation
rehabilitation (CR) programme using the Family- What is already known about this subject?
using the Family-Centered
Empowerment Model versus
Centered Empowerment Model (FCEM) as compared Cardiac rehabilitation (CR) is an outpatient
home-based cardiac with standard CR will improve patient quality of life, model of chronic disease management for sec-
rehabilitation in patients with perceived stress and state anxiety of patients with ondary cardiovascular disease (CVD) prevention.
myocardial infarction: myocardial infarction (MI). It is a class I indication for patients with coron-
a randomised controlled trial. Methods: We conducted a randomised controlled trial ary heart disease. The use of CR post-
Open Heart 2016;3:e000349. in which patients received either standard home CR or myocardial infarction ( post-MI) has been shown
doi:10.1136/openhrt-2015- CR using the FCEM strategy. Patient empowerment was to improve function and exercise capacity,
000349 measured with FCEM questionnaires preintervention decrease morbidity and mortality, and also
and postintervention for a total of 9 assessments. improves quality of life, perceived stress and
Quality of life, perceived stress, and state and trait anxiety. Hence, CR serves as a key tool in
Received 6 October 2015 anxiety were assessed using the 36-Item Short Form addressing the global burden of CVD. Despite
Revised 14 March 2016 Health Survey (SF-36), the 14-item Perceived Stress, recommendations, CR remains underutilised
Accepted 15 March 2016 and the 20-item State and 20-item Trait Anxiety with low participation and adherence rates both
questionnaires, respectively. in high income countries and low and middle
Results: 70 patients were randomised. Baseline income countries (LMICs). Home-based and
characteristics were similar. Ejection fraction was hybrid CR programmes developed as a means
significantly higher in the intervention group at to increase patient access, compliance and
measurements 2 ( p=0.01) and 3 ( p=0.001). Exercise enrolment.
tolerance measured as walking distance was The Family-Centered Empowerment Model
significantly improved in the intervention group (FCEM) was designed to improve the care and
throughout the study. The quality of life results in the outcomes of patients with chronic diseases and
FCEM group showed significant improvement both has previously been evaluated and validated in a
within the group over time ( p<0.0001) and when number of chronic disease states. Previously, it
compared with control ( p<0.0001). Similarly, the has been shown that the FCEM model may be
perceived stress and state anxiety results showed feasible to use in the cardiac setting. Moreover,
significant improvement both within the FCEM group it has been reported to be effective among
over time ( p<0.0001) and when compared with control patients undergoing coronary artery bypass
( p<0.0001). No significant difference was found either surgery. Its use in the non-surgical post-MI
within or between groups for trait anxiety. setting has not been defined.
Conclusions: The family-centred empowerment
model may be an effective hybrid cardiac rehabilitation
For numbered affiliations see method for improving the physical and mental health
end of article. INTRODUCTION
of patients post-MI; however, further study is needed
Cardiovascular disease (CVD) is a leading
to validate these findings. Clinical Trials.gov identifier
Correspondence to NCT02402582. cause of death worldwide, accounting for
Dr Fatemah Alhani; Trial registration number: NCT02402582. 30% of global deaths.1 Over the next few
Alhani_f@modares.ac.ir decades, CVD will continue as the leading

Vahedian-Azimi A, Miller AC, Hajiesmaieli M, et al. Open Heart 2016;3:e000349. doi:10.1136/openhrt-2015-000349 1


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Open Heart

or hybrid CR programmes is associated with cost-


KEY QUESTIONS effective and equivalent benets to supervised pro-
What does this study add? grammes.2224 With advances in technology, hybrid
CR remains underutilised and with high rates of patient attri- home-based programmes have been developed that
tion. This study utilises an approach to support structure incorporate email, secure websites and videoconferen-
engagement that has not previously been used in the post-MI cing between patients and providers. Recently, the
population. Marked improvements in patient perceived physical utility of smartphone applications has also been
and mental wellness as well as quality of life were observed. investigated.21
Improvements in ejection fraction and exercise tolerance were The Family-Centered Empowerment Model (FCEM)
also observed. This strategy may effectively augment home CR was designed and rst reported by Dr Fatemah Ahlani at
to improve its effectiveness. Tarbiat Modarres University.25 Its aim was to improve
How might this impact on clinical practice? the care and outcomes of patients with chronic diseases
This study suggests that use of the FCEM to augment home and has previously been evaluated and validated in a
CR may improve patients physical health, mental health and number of chronic disease states.7 2632 The primary aim
quality of life versus attenuating the decline that may occur fol- of the model is to empower the patient/family unit to
lowing discharge for acute MI. This may have the greatest clin- promote health quality. The model has four stages: (1)
ical implications in resource-limited settings where CR access determining perceived threat (group discussion
is low and attrition rates are high. method); (2) self-efcacy ( problem-solving method);
(3) improving self-esteem (educational participation
method) and (4) process and outcome evaluations. We
cause of mortality worldwide.2 3 Furthermore, the investigated the impact that an FCEM-focused hybrid CR
burden of CVD is growing disproportionately in low and programme employing in-hospital and outpatient com-
middle income countries (LMICs), where 80% of CVD ponents, direct education, video teleconferencing and
deaths occur.4 Myocardial infarction (MI) is a leading smartphone technology had on patient anxiety and per-
cause of CVD-associated morbidity and mortality.57 ceived stress, and overall quality of life has measured by
Recurrent MI within 5 years is common, affecting HRQoL among patients hospitalised with acute MI
1522% of patients aged 4564 years and 22% of (AMI) in a coronary care unit (CCU).
patients aged >65 years.6 In addition to the physical toll,
an MI may cause or exacerbate signicant mental health
comorbid conditions. METHODS
The health-related quality of life (HRQoL) is increas- Study design
ingly being used as an outcome measure of coronary We conducted a randomised controlled blinded study in
heart disease.810 As the population ages and survival of patients admitted for MI to the CCU of an academic
ischaemic coronary events continues to improve, assess- teaching hospital from June 2012 to January 2015. The
ment of HRQoL is necessary as an important and useful study was approved by the institutional investigative
outcome measure complementing the traditional hard review board at Tarbiat Modares University and
outcomes such as mortality and recurrent MI for evalu- Baqiyatallah University of Medical Sciences and regis-
ating impact of disease and benets of medical interven- tered with Clinical Trials.gov (identier NCT02402582).
tions.8 Post-MI increases in patient stress may translate Inclusion criteria were: (1) age 4585 years, (2) able and
into worse HRQoL.6 1113 Evidence suggests that a willing to provide informed consent, (3) willingness of
decline in health status is associated with worse progno- designated family member or friend to participate, (4) is
sis, disease progression and healthcare outcomes in able to read, write, and ll out the questionnaire, (5)
patients with cardiac disease.12 1416 diagnosed with an AMI and (6) rst hospitalisation for
Cardiac rehabilitation (CR) is an outpatient model of AMI. MI was diagnosed in accordance with established
chronic disease management for secondary CVD pre- criteria including (1) clinical symptoms, (2) serum tests
vention. It is a class I indication for patients with coron- (eg, troponin and creatine kinase (CK)-MB) and (3)
ary heart disease.17 In a meta-analysis, the use of CR characteristic changes on the ECG. Cardiac catheterisa-
post-MI has been shown to improve function and exer- tion data were not routinely available. Patients had not
cise capacity, decrease morbidity and mortality, and also previously gone through CR programmes. The differ-
improves quality of life, perceived stress and anxiety.1 18 ence between the two groups was not disclosed at any
Hence, CR serves as a key tool in addressing the global point. Patients consented knowing that they would
burden of CVD.1 Despite recommendations, CR receive cardiac rehabilitation, but without knowing the
remains underutilised with low participation and adher- details. Patients and their designated family/friend were
ence rates in both high income and LMICs.1 The enrolled as a unit.
reasons for CR underuse include geographic access, Power calculations determined that 32 patient/family
cost, organisational and patient factors, and patient units were needed in each group to achieve a 95% con-
education and understanding of the nature of CR and dence level and a 90% power. Participant enrolment was
the associated benets.1921 Participation in home-based via convenience sampling. Block randomisation was

2 Vahedian-Azimi A, Miller AC, Hajiesmaieli M, et al. Open Heart 2016;3:e000349. doi:10.1136/openhrt-2015-000349


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Cardiac risk factors and prevention

accomplished by a computer-generated random number received care employing the FCEM in four stages. Stage 1
list prepared by an expert statistician who had no clinical of the intervention was awareness and cognition. The
involvement in the trial. Allocation consignment was patient was evaluated for their insight into their perceived
performed by the hospital clinical supervisor, who was illness severity and perceived sensitivity, or the degree to
not involved in the recruitment process. Patients and which they felt threatened by their illness.32 This was per-
their family members, clinical nurses and data analyser formed by means of 35 group sessions in the preinter-
were blind to the allocation. Analyses were performed as vention phase. Group sessions included 35 patients and
intention-to-treat. lasted for 4560 min each. Session content included
assessments of the participants psychological and phys-
Intervention ical conditions as well as their attitude towards the nature,
The intervention package had three phases including denition, risk factors, symptoms, medical and nursing
the preintervention, intervention and postintervention care, and complications resulting from the MI.
phases (gure 1). In stage 2, patients were assessed for their expectations
over 35 1 h sessions.32 Groups of 34 patients shared
Preintervention and learnt from each other under the moderation and
During the preintervention phase, patients lled out guidance of the principal researcher.
questionnaires concerning quality of life, perceived In stage 3, the degree of patient acceptance was assessed
stress and anxiety. A rehabilitation plan was formulated using an educational participation method in group dis-
incorporating considerations for the patients identied cussion. Patients reached practical solutions through
strengths and weaknesses. See the CR section. using the problem-solving ndings of the previous stage.
Stage 4 consisted of formative and summative evalua-
Intervention tions.32 The aim of the formative evaluation was to
Once discharged, patients called their study nurse every encourage patients to internalise their locus of control
2 days to report any problems or complications. Patients by seeing his/her self-empowerment (increasing self-
were evaluated by their primary cardiologist on a weekly responsibility about their health). Summative evaluations
basis and at 30 days. These examinations included were performed to evaluate the inuence of the inter-
history and physical examination, an ECG, and echocar- vention on HRQoL dimensions, perceived stress and
diogram and laboratory tests as indicated. At other anxiety. The HRQoL dimensions, perceived stress and
times, if patients experienced a problem or complica- anxiety were assessed at baseline and at 3 months post-
tion, they notied investigators and presented to either intervention. Empowerment was measured at baseline
their primary cardiologist or their primary care provider and at 10 days postintervention by deploying FCEM
for evaluation. Patients in the intervention group questionnaires.

Figure 1 Study overview and design. AMI, acute myocardial infarction; CK, creatine kinase; FCEM, Family-Centered
Empowerment Model; SF-36, 36-Item Short Form Health Survey.

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Open Heart

Postintervention follow-up were provided printed materials, with dietician assess-


Phase 3 began 90 days following preintervention ments available on request.
(control group), and 90 days postintervention (FCEM Patients in the control group received the same educa-
group). To assess the durability and stability of patient tion and printed materials during their inpatient course.
empowerment, patient knowledge, attitude and practice Patients exercised daily, at any time, for 2 h according
(KAP) was assessed over eight follow-up sessions at to patient tolerance. Sessions were supervised by family
3-month intervals. During the 24-month follow-up members. Investigators did not attend sessions. Exercise
period, patients attended a total of 21 support-group data were independently collected from the patient and
webinars addressing topics including returning to work, their designated family member on a weekly basis ( stat-
intimate relationships, nutrition, sleep hygiene, tobacco istic=0.4). Again, walking distance was measured using
use, exercise, and leisure activities and testing or labora- the Fitbit. Routine care included education on smoking
tory issues. Follow-up interviews were conducted during cessation and education on food selection. Patients were
home visits, when available, or with the assistance of tele- provided printed materials, with dietician assessments
phone, Skype, Viber or WhatsApp according to patient available on request.
preference.
Data collection
Role of the designee Data collection tools consisted of six questionnaires
Following informed consent, the designated family including (1) demographic variables, (2) the FCEM, (3)
member or friend (hereafter called designee) continued the 36-Item Short Form Health Survey (SF-36), (4) the
through the study with the patient as a unit. The perceived stress, and (5) State and (6) Trait Anxiety
designee attended the patients educational sessions questionnaires. In addition to questionnaires, results of
during stages 3 and 4, with stage 2 being according to serum creatinine, ejection fraction as measured on echo-
the family member preference. Recall that stage 2 deals cardiography, and cardiac catheterisation and stenting
with patient expectations, stage 3 with patient accept- were also recorded.
ance and problem-solving, and stage 4 with evaluations
and internalising his/her locus of control. The designee The FCEM questionnaire
and the patient attended the same sessions, and studied The FCEM questionnaire consisted of four dimensions:
the same learning materials. Up to four family members perceived threat, self-efcacy, self-esteem, and summative
were allowed to join in the educational sessions if and formative evaluations.7 32 Degree of patient
requested. In stage 3, the designee was charged with empowerment was assessed via KAP questions. Each
learning and reinforcing educational material with the question was scored on a scale of 17 representing least
patient. In stage 4, when instructed by study investiga- to most empowerment, respectively. The maximum ques-
tors, the designee would administer the KAP assessments tionnaire score was 826, and the lowest acceptable score
to the patient. In addition to scores, the designee would was 620 (sensitivity 95%, specicity 96%).To determine
provide additional information on the patients home the lowest acceptable postintervention score, analysis of
situation and current condition. Patients were assigned a the receiver operating characteristic (ROC) curve was
code, and de-identied data were transmitted from the performed and discussed in two qualitative expert panel
designee to investigators either by encrypted email, tele- rounds. Each expert panel consisted of 10 professional
phone, mail or in person. members (2 cardiologists, 1 intensivist, 1 nutritionist, 3
registered nurses, 1 psychologist, 1 psychiatrist and 1
Rehabilitation plan physiatrist) and 22 patient/family member units. The
All patients had similar inpatient rehabilitation pro- agreement correlation coefcient among the two quali-
grammes. For patients in the FCEM group, outpatients tative expert panel rounds results was 0.92.
included daily exercise for 02 h/day. Exercise Validity of the FCEM questionnaires was assessed by
occurred between 8:00 and 10:00, and types included face and content validities through both qualitative and
walking, jogging, bicycle, swimming, or other exercise quantitative means. Impact score of the questionnaire
according to patient preference or resource availability. was calculated at 3.01; content validity ratio (CVR) with
Daily exercise was supervised by designated family 10 panellists and Content Validity Index (CVI) were cal-
members. Investigators randomly attended sessions in culated at 0.78 and 0.85, respectively. The reliability of
an unannounced fashion. Although not routinely the FCEM questionnaire was assessed by testretest and
involved, physical therapy consultation was available on Cronbachs that was calculated at 0.89 and 0.92,
investigator request. Exercise data were independently respectively.32
collected from the patient and their designated
family member on a weekly basis ( statistic=0.9). To SF-36 questionnaire
measure the patients walking distance, investigators The questionnaire consists of eight domains including
provided them with a Fitbit (Fitbit, San Francisco, physical functioning, physical role limitation, social func-
USA). Routine care included education on smoking tioning, bodily pain, mental health, mental role limita-
cessation and education on food selection. Patients tion, vitality and general health. Scoring of each domain

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Cardiac risk factors and prevention

was calculated independently and scores ranged from 0 group and one in the intervention group. Seven
(the worst) to 100 (the best).32 33 The SF-36 question- patients were lost to follow-up, including ve in the
naire is a validated tool33 34 whose reliability in this study control group and two in the intervention group.
was assessed by testretest and Cronbachs at 0.90 and Patient demographics were similar between groups
0.93, respectively. (table 1).

The 14-item Perceived Stress Questionnaire (PSQ-14) Clinical and physiological variables
Overall stress was measured using the validated ST segment elevation MI was identied in 33 (94%)
PSQ-14.35 36 PSQ-14 scores are obtained by reversing the patients in the intervention group and 31 (89%) in the
scores on the seven positive items, including 0=4, 1=3, control group ( p=0.77). Non-ST segment elevation MI
2=2, 3=1 and 4=0, then, summing across all 14 items. was identied in 2 (6%) versus 4 (11%) patients
Scores range from 14 to70.37 The reliability of the ( p=0.70). The incidence of cardiac catheterisation was
PSQ-14 was assessed in this study by test-retest and similar between groups (55% vs 40%; p=0.87). Among
Cronbachs at 0.93 and 0.92, respectively. those undergoing cardiac catheterisation, rates of stent
placement did not differ signicantly (45% vs 60%;
The State and Trait Anxiety questionnaire p=0.62). Although the baseline ejection fraction did not
Patient anxiety was assessed through the StateTrait differ signicantly between groups (table 2), the mean
Anxiety questionnaire. This validated tool has 20 items and median ejection fractions were signicantly higher
for assessing trait anxiety and state anxiety, respect- in the intervention group at measurements 2 ( p=0.01)
ively.38 39 All items are rated on a four-point scale and 3 ( p=0.001).
ranging from very low (1 point) to very high (4 points). There were no events of repeat MI or emergent revas-
Higher scores indicate greater anxiety.38 39 The reliabil- cularisation in either group during the study period.
ity of the StateTrait Anxiety questionnaire was assessed Renal function was similar between the intervention
in this study by testretest and Cronbachs at 0.89 and and control groups. Serum creatinine did not differ
0.90, respectively. between groups at baseline (1.480.34 vs 1.390.40;
p=0.36), measurement 2 (1.280.34 vs 1.200.40; p=0.41)
Data analysis and measurement 3 (1.080.34 vs 1.020.40; p=0.55).
All analyses were performed using SPSS 22.0 (SPSS Inc, Pearson and Spearman correlation coefcients (r)
Chicago, IL). Frequency ( per cent) and mean (SD) were used to compare exercise, weight loss and smoking
were presented for qualitative variables (gender, marital cessation (data not presented). The correlation coef-
status, educational level, job and location of residence) cients for exercise (r=0.90), weight loss (r=0.88) and
and quantitative variables (age, body mass index and smoking cessation (r=0.90) indicate that changes in
family size). Demographic variables were analysed using these variables were similar between groups.
the 2 test and independent Students t test. The nor- Exercise tolerance was further addressed by measuring
mality in variable distribution was analysed using the the walking distance once a month. The mean walking
Kolmogorov-Smirnov test ( p>0. 05). For the outcome distance was similar between groups at baseline but stat-
measures of quality of life, perceived stress and istically improved in the FCEM group relative to controls
state-and-trait anxiety, repeated measures analysis of vari- (gure 2).
ance (RANOVA) was performed followed by Sidak post
hoc test. Quality of life
The assumption of the sphericity of the covariance In this study, eight dimensions of quality of life were
matrix was evaluated using Mauchlys test and, depend- summarised in two comprehensive domains including
ing on the results of this test, p values were presented on physical dimensions ( physical functioning, physical role
the basis of the Greenhouse-Geisser correction. In add- limitation, bodily pain and general health) and mental
ition, Hotellings T2 tests were used to evaluate the dif- dimensions (social functioning, mental health, mental
ferences between the intervention and control groups at role limitation and vitality). The results of the RANOVA
all time points, followed by independent samples model for physical and mental dimensions showed sig-
Students t tests for investigating the differences between nicant changes within and between groups over time
the intervention and control groups separately. p Values ( p<0.0001) (table 3).
<0.05 were considered signicant. Although the baseline physical health scores were
similar between groups ( p=0.24), by the rst postinter-
vention assessments scores were signicantly higher in
RESULTS the experimental group ( p<0.0001) and remained so
A total of 127 eligible patients were screened for the throughout the duration of the study (table 3). Similarly,
study. Fifty-one did not meet the inclusion criteria and the preintervention mental health scores were similar
six declined to participate. Seventy patientfamily units between groups ( p=0.48) but displayed a trend towards
were included and evenly randomised into two groups. signicant improvement in the experimental group by
Three patients died, including two in the control the rst postintervention assessment and remained

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Open Heart

Table 1 Patient demographics


Total (n=70) Intervention Control group Statistical test
Characteristics MeanSD group (n=35) (n=35) and p Value
Age
MeanSD 61.4012.83 62.0014.18 60.8011.51 t=0.389*
p=0.699
BMI
MeanSD 24.873.80 24.703.5 25.34.12 t=0.364*
p=0.717
Family number
MeanSD 5.371.91 5.21.94 5.541.91 t=0.754*
p=0.454
Gender, n (%)
Male 46 (65.7%) 22 (62.9%) 24 (68.6%) 2=2.470
Female 24 (34.3%) 13 (37.1%) 11 (31.4%) df=1
p=0.116
Marital Status, n (%)
Single 1 (1.4%) 1 (2.9%) 0 (0.00%)
Married 69 (98.6%) 34 (97.1%) 35 (100.0%)
Living location, n (%)
City 36 (51.4%) 20 (57.1%) 16 (45.7%) 2=0.345
Countryside 34 (48.6%) 15 (42.9%) 19 (54.3%) df=1
p=0.557
Job, n (%)
Clerk 12 (17.1%) 4 (11.4%) 8 (22.9%) 2=29.085
Labourer 8 (11.4%) 4 (11.4%) 4 (11.4%) df=25
Housekeeper 23 (32.9%) 13 (37.1%) 10 (28.6%) p=0.260
Unemployed 3 (4.3%) 1 (2.9%) 2 (5.7%)
Retired 11 (15.7%) 5 (14.3%) 6 (17.1%)
Non-governmental 13 (18.6%) 8 (22.9%) 5 (14.3%)
Education level, n (%)
Primary 19 (27.1%) 8 (22.9%) 11 (31.4%) 2=8.809
Secondary 30 (42.9%) 17 (48.6%) 13 (37.1%) df=4
High/undergraduate 21 (30.0%) 10 (28.6%) 11 (31.4%) p=0.066
*Based on the independent Students t test.
Based on the 2 test.
BMI, body mass index.

signicant throughout the duration of the study groups ( p=0.48). A signicant time trend was observed
( p<0.0001). in the intervention group ( p<0.0001) with interaction
between time and group ( p<0.0001; table 4).
Effect of the FCEM on perceived stress No signicant time trend was noted in the control
The results of the RANOVA model showed similar base- group ( p=0.143). Of note, the difference within groups
line values between the control and experimental was achieved by the rst follow-up assessment and

Table 2 Comparison of systolic ejection fraction between groups


Systolic ejection fraction Systolic ejection fraction
(mm Hg) (mm Hg)
FCEM Control
(n=35) (n=35) FCEM Control Within Within Between
Median Median (n=35) (n=35) FCEM control groups
Time (Q1Q3) (Q1Q3) p Value* MeanSD MeanSD p Value* p Value p Value p Value
Preintervention 44 (3350) 37 (3443) 0.12 41.778.63 38.866.73 0.12 0.001 0.869 0.001
Measurement 2 46 (3452) 38 (3343) 0.01 43.438.65 38.666.79 0.01
Measurement 3 47 (3653) 38 (3344) 0.001 45.208.62 38.896.58 0.001
*p Value based on independent samples Students t test.
p Value based on RANOVA.
FCEM, Family-Centered Empowerment Model; RANOVA, repeated measured analysis of variance.

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Cardiac risk factors and prevention

factors.1 Additionally, it has been reported to have bene-


cial effects on quality of life, perceived stress and
anxiety.18 41 Patients who participate in CR tend to have
a higher HRQoL and improved markers of mental
health such as work resumption, and less stress and
anxiety. It has been shown that about 80% of partici-
pants attending CR return to physical, mental and psy-
chosocial functioning (including work) 1 year
post-hospitalisation for MI.42 Although cost-effective in
high-income countries, this has not been studied in
LMICs.1 20 Despite recommendations, CR remains
underutilised with low participation and adherence rates
in both high income and LMICs.1 In the USA, fewer
than 30% of eligible patients participate in these pro-
grammes,43 and fewer than 20% of eligible patients are
referred to these programmes.44 Rates in Iran have not
been well described. Many reasons for this underutilisa-
tion have been cited including age, female gender, geo-
graphic access, low socioeconomic status, organisational
and patient factors, and patient education and under-
Figure 2 Distance walked daily. FCEM, Family-Centered
Empowerment Model. standing of the nature of CR and the associated bene-
ts.1921 45 Additionally, lower enrolment and higher
maintained throughout the duration of the study dropout rates have been seen with patients with coexist-
( p<0.0001). ing poor functional capacity and exercise habits,
tobacco use and depression with an onset pre-CR.46
As a means to improve patient accessibility and com-
Effect of the FCEM on state and trait anxiety
pliance to CR programmes, both hybrid and home-
The results of the RANOVA model for state anxiety
based programmes were developed. Hybrid programmes
showed similar preintervention values between groups
incorporate both an ambulatory and home-based com-
( p=0.84) but signicant improvement in state anxiety
ponent. Participation in hybrid and home-based CR is
between groups by the rst postintervention assessment
associated with cost-effective and equivalent benets to
( p<0.0001; table 5).
supervised programmes and offers support to maintain
This trend persisted for the duration of the study. The
motivation, address anxiety and seek information.2224
time trend was signicant in the intervention group and
With advances in technology, hybrid home-based pro-
displayed interaction between time and group
grammes have been developed that incorporate email,
( p<0.0001), but no signicant time trend was observed
secure websites and video conferencing between patients
within the control ( p=0.063) in the control group.
and providers. Recently, the utility of smartphone appli-
When assessing trait anxiety, the RANOVA model
cations to improve CR utilisation has also been investi-
showed no signicant time trend for either the interven-
gated.21 47 It has been shown that hybrid CR may be a
tion ( p=0.089) or control ( p=0.095) group, and inter-
viable and effective tool in rural Iran.48
action between time and group ( p=0.075). Overall, no
The FCEM is a model that we adapted to hybrid CR
signicant difference in trait anxiety was observed
for the purpose of improving patient quality of life. It
between groups (table 5).
was initially designed to improve the care and outcomes
of patients with chronic diseases and has previously
DISCUSSION been evaluated and validated in a number of chronic
CR is an outpatient model of chronic disease manage- disease states.7 25 26 28 30 31 49 50 Previously, it has been
ment for secondary CVD prevention and is a class I indi- shown that the FCEM model may be feasible to use in
cation for patients with coronary heart disease.17 It can the cardiac setting.7 32 Moreover, it has been reported to
be dened as The coordinated sum of activities be effective among patients undergoing coronary artery
required to inuence favorably the underlying cause of bypass surgery.26 We investigated whether FCEM in the
cardiovascular disease, as well as to provide the best pos- post-MI care and CR process is an effective means to
sible physical, mental and social conditions, so that the decrease anxiety and perceived stress, and improve
patients may, by their own efforts, preserve or resume HRQoL in patients hospitalised for MI. This was the rst
optimal functioning in their community and through study of its kind in this population. Control patients
improved health behavior, slow or reverse progression of received standard CR while those in the intervention
disease.40 In a meta-analysis, CR signicantly reduced group received CR via the FCEM. For patients in the
all-cause mortality by 1326%, cardiac mortality by 20 FCEM group, the designated key support relationships
36%, myocardial re-infarction by 2547%, and risk were identied and incorporated into their treatment

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Open Heart

Table 3 Quality of life dimensions including physical and mental health domains as determined by the SF-36 Questionnaire
p Value within p Value within p Value
Intervention Control the FCEM the control between
Domain Measurement (meanSD) (meanSD) p Value* group group groups
Physical health Baseline 52.769.59 50.119.58 0.242 <0.0001 <0.0001 <0.0001
Measurement 2 82.056.40 25.69.44 <0.0001
Measurement 3 82.049.30 26.068.20 <0.0001
Follow-up 1 81.017.20 24.2410.24 <0.0001
Follow-up 2 86.134.51 27.817.61 <0.0001
Follow-up 3 88.373.42 20.104.65 <0.0001
Follow-up 4 88.543.35 22.917.15 <0.0001
Follow-up 5 88.313.49 22.257.69 <0.0001
Follow-up 6 87.663.47 27.537.12 <0.0001
Follow-up 7 81.017.20 34.2410.24 <0.0001
Follow-up 8 85.214.65 23.014.87 <0.0001
Mental health Baseline 51.929.51 53.6410.87 0.483 <0.0001 <0.0001 <0.0001
Measurement 2 80.117.40 23.358.34 <0.0001
Measurement 3 81.217.30 25.256.34 <0.0001
Follow-up 1 79.416.20 24.157.14 <0.0001
Follow-up 2 85.723.23 24.437.82 <0.0001
Follow-up 3 85.173.34 18.334.45 <0.0001
Follow-up 4 84.693.45 22.897.56 <0.0001
Follow-up 5 84.783.86 24.528.15 <0.0001
Follow-up 6 84.043.78 21.745.93 <0.0001
Follow-up 7 79.416.20 24.157.14 <0.0001
Follow-up 8 83.863.81 20.445.48 <0.0001
*p Value based on independent samples Students t test.

p Value based on repeated measures ANOVA. Dependent on the results of Mauchlys test, p values presented are based on the
Greenhouse-Geisser test.
ANOVA, analysis of variance; FCEM, Family-Centered Empowerment Model; SF-36, 36-Item Short Form Health Survey.

plan. Through stage 1, patients are encouraged to learn control. In this way, patients are being taught techniques
about themselves and their health so that they may be to cope with their chronic illness over the long haul.
able to identify the ways in which they feel threatened by In this study, we found improvements in physical
their illness. They then learn to assess their expectations health, mental health and quality of life in those
of these situations (stage 2), and brainstorm in groups patients receiving home CR using the FCEM as com-
via the educational participation method to develop pared with those receiving standard home CR. The
practical solutions (stage 3). Lastly, patients are taught to reasons for improvement are most likely multifactorial
do a self-assessment and internalise their locus of and may include patient encouragement, greater patient

Table 4 Perceived stress assessment


Intervention Control p Value within the p Value within the p Value between
Measurement (meanSD) (meanSD) p Value* FCEM group control group groups
Baseline 34.573.83 33.492.71 0.483 <0.0001 0.143 <0.0001
Measurement 2 67.690.91 32.693.11 <0.0001
Measurement 3 70.260.54 31.613.10 <0.0001
Follow-up 1 68.171.51 34.513.25 <0.0001
Follow-up 2 68.460.95 33.602.06 <0.0001
Follow-up 3 68.341.14 34.002.24 <0.0001
Follow-up 4 68.541.07 33.772.36 <0.0001
Follow-up 5 68.341.06 34.372.21 <0.0001
Follow-up 6 68.401.19 33.632.30 <0.0001
Follow-up 7 68.601.38 34.351.97 <0.0001
Follow-up 8 64.711.98 33.662.11 <0.0001
*p Value based on independent samples Students t test.

p Value based on repeated measures ANOVA. Dependent on the results of Mauchlys test, p values presented are based on the
Greenhouse-Geisser test.
ANOVA, analysis of variance; FCEM, Family-Centered Empowerment Model.

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Cardiac risk factors and prevention

Table 5 State and trait anxiety assessment


p Value within p Value within p Value
Intervention Control the FCEM the control between
Anxiety type Measurement (meanSD) (meanSD) p Value* group group groups
State anxiety Baseline 55.377.21 55.066.23 0.846 <0.0001 0.143 <0.0001
Measurement 2 53.237.98 73.146.05 <0.0001
Measurement 3 54.304.32 76.094.54 <0.0001
Follow-up 1 55.836.69 71.345.40 <0.0001
Follow-up 2 55.116.16 74.343.51 <0.0001
Follow-up 3 54.696.43 72.315.10 <0.0001
Follow-up 4 55.295.56 71.974.94 <0.0001
Follow-up 5 55.006.34 71.714.10 <0.0001
Follow-up 6 53.094.97 72.005.04 <0.0001
Follow-up 7 51.943.12 71.944.43 <0.0001
Follow-up 8 54.235.30 72.264.24 <0.0001
Trait anxiety Baseline 54.494.36 53.433.85 0.285 0.089 0.095 0.075
Measurement 2 52.234.17 53.404.56 0.921
Measurement 3 51.234.80 53.295.54 0.729
Follow-up 1 53.863.87 52.204.63 0.109
Follow-up 2 53.433.85 54.494.36 0.406
Follow-up 3 52.204.63 53.863.87 0.801
Follow-up 4 54.063.69 54.144.39 0.930
Follow-up 5 52.204.63 53.433.85 0.231
Follow-up 6 54.494.36 52.204.63 0.099
Follow-up 7 53.204.63 52.204.63 0.942
Follow-up 8 55.063.69 54.063.70 0.843
FCEM, Family-Centered Empowerment Model.
*P-value based on independent samples T-test.

P-value based on repeated measures ANOVA. Dependent on the results of Mauchlys test, P-values presented are based on the
Greenhouse-Geiser test.

understanding, positive reinforcement and the sense of health situation. Moreover, our interventions did not
accountability. This is reected in the results of physical incorporate mandatory therapy or interventions that
and mental health scores. Baseline scores were similar would change the trait anxiety of patients; thus, these
between groups; however, following deployment of the levels remained stable.
FCEM with its educational and support groups and use Further study is needed to discern whether the FCEM
of remote follow-up (telephone, Skype, Viber or is really improving patient health versus attenuating the
WhatsApp), there was a sharp discrepancy between decline that may occur following discharge for AMI. It
groups favouring the FCEM-enhanced CR over standard may be that the FCEM method augments and maintains
home-based CR. Similar results were observed for per- the education and empowerment that patients receive
ceived stress and state anxiety. The non-signicance of during their inpatient course. Additionally, the long-
the trait anxiety ndings is important. State anxiety term sustainability of this method in this setting remains
refers to a temporary condition in response to some per- to be investigated.
ceived threat. Trait anxiety refers to the differences
between people in terms of their tendency to experi-
ence state anxiety in response to the anticipation of a CONCLUSION
threat (ie, anxiety proneness). Thus, trait anxiety The FCEM is an effective CR method for improving a
describes a personality characteristic rather than a tem- patients mental health and personal assessments of
porary feeling. Although traits are enduring features physical health following AMI.
which are part of ones personality, the expression of a
trait can be changed over time, for example, with the LIMITATIONS
use of long-term therapy. The importance of measuring Physical health was measured by the validated SF-36
trait anxiety in this study was to demonstrate that anxiety questionnaire. Data regarding specic modiable risk
proneness, or the ability to generate state anxiety, was factors (blood pressure, cholesterol, glycated haemoglo-
similar between groups. We observed stable levels of trait bin) were not recorded.
anxiety in both groups throughout the study. We believe
that the attenuation in the rise in situational, or state, Author affiliations
anxiety in the interventional group is a reection of the 1
Trauma Research Center and Nursing Faculty, Baqiyatallah University of
patients sense of empowerment in managing their Medical Sciences, Tehran, Iran

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Open Heart
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Cardiac rehabilitation using the


Family-Centered Empowerment Model versus
home-based cardiac rehabilitation in patients
with myocardial infarction: a randomised
controlled trial
Amir Vahedian-Azimi, Andrew C Miller, Mohammadreza Hajiesmaieli,
Mari Kangasniemi, Fatemah Alhani, Hosseinali Jelvehmoghaddam,
Mohammad Fathi, Behrooz Farzanegan, Seyed H Ardehali, Sevak
Hatamian, Mehdi Gahremani, Seyed M M Mosavinasab, Zohreh Rostami,
Seyed J Madani and Morteza Izadi

Open Heart 2016 3:


doi: 10.1136/openhrt-2015-000349

Updated information and services can be found at:


http://openheart.bmj.com/content/3/1/e000349

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References This article cites 48 articles, 6 of which you can access for free at:
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