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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.

ABSTRACT: To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI).We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and postintervention for a total of 9 assessments. Quality of life, perceived stress, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively.70 patients were randomised. Baseline characteristics were similar. Ejection fraction was significantly higher in the intervention group at measurements 2 (p=0.01) and 3 (p=0.001). Exercise tolerance measured as walking distance was significantly improved in the intervention group throughout the study. The quality of life results in the FCEM group showed significant improvement both within the group over time (p<0.0001) and when compared with control (p<0.0001). Similarly, the perceived stress and state anxiety results showed significant improvement both within the FCEM group over time (p<0.0001) and when compared with control (p<0.0001). No significant difference was found either within or between groups for trait anxiety.The family-centred empowerment model may be an effective hybrid cardiac rehabilitation method for improving the physical and mental health of patients post-MI; however, further study is needed to validate these findings. Clinical Trials.gov identifier NCT02402582.NCT02402582.

SUBMITTER: Vahedian-Azimi A

PROVIDER: S-EPMC4838765 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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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.

Vahedian-Azimi Amir A Miller Andrew C AC Hajiesmaieli Mohammadreza M Kangasniemi Mari M Alhani Fatemah F Jelvehmoghaddam Hosseinali H Fathi Mohammad M Farzanegan Behrooz B Farzanegan Behrooz B Ardehali Seyed H SH Hatamian Sevak S Gahremani Mehdi M Mosavinasab Seyed M M SM Rostami Zohreh Z Madani Seyed J SJ Izadi Morteza M

Open heart 20160419 1

<h4>Objective</h4>To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI).<h4>Methods</h4>We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and pos ...[more]

PMID: 27110376

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Project description:BackgroundGiven the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly).ObjectivesThis study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial.MethodsThe trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks.ResultsMACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes).ConclusionsYoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408).

Project description:ImportanceCardiac rehabilitation (CR) improves survival after acute myocardial infarction (AMI), and referral to CR has been introduced as a performance measure of high-quality care. The association of participation in CR with patients' health status (eg, quality of life, symptoms, and functional status) is poorly defined.ObjectiveTo examine the association of participation in CR with health status outcomes after AMI.Design, setting, and participantsA retrospective cohort study was conducted of patients enrolled in 2 AMI registries: PREMIER, from January 1, 2003, to June 28, 2004, and TRIUMPH, from April 11, 2005, to December 31, 2008. The analytic cohort was restricted to 4929 patients with data available on baseline health status, 6- or 12- month follow-up health status, and participation in CR. Data analysis was performed from 2014 to 2015.ExposuresParticipation in at least 1 CR session within 6 months of hospital discharge.Main outcomes and measuresPatient health status was quantified using the Seattle Angina Questionnaire (SAQ) and the 12-Item Short-Form Health Survey (SF-12). The primary outcomes of interest were the mean differences in SAQ domain scores during the 12 months after AMI between patients who did and did not participate in CR. Secondary outcomes were the mean differences in the SF-12 summary scores and all-cause mortality.ResultsAfter successfully matching the cohorts of the 4929 patients (3328 men and 1601 women; mean [SD] age, 60.0 [12.2] years) for the propensity to participate in CR and comparing the groups using linear, mixed-effects models, mean differences in the SAQ and SF-12 domain scores were similar at 6 and 12 months between the 2012 patients participating in CR (3 were unable to be matched) and the 2894 who did not participate (20 were unable to be matched). At 6 months, the mean difference was -0.76 (95% CI, -2.05 to 0.52) for the SAQ quality of life score, -1.53 (95% CI, -2.57 to -0.49) for the SAQ angina frequency score, 0.38 (95% CI, -0.51 to 1.27) for the SAQ treatment satisfaction score, -0.42 (95% CI, -1.65 to 0.79) for the SAQ physical limitation score, 0.50 (95% CI, -0.22 to 1.22) for the SF-12 physical component score, and 0.13 (95% CI, -0.53 to 0.79) for the SF-12 mental component score. At 12 months, the mean difference was -0.89 (95% CI, -2.20 to 0.43) for the SAQ quality of life score, -1.05 (95% CI, -2.12 to 0.02) for the SAQ angina frequency score, 0.38 (95% CI, -0.54 to 1.29) for the SAQ treatment satisfaction score, -0.14 (95% CI, -1.41 to 1.14) for the SAQ physical limitation score, 0.17 (95% CI, -0.57 to 0.92) for the SF-12 physical component score, and 0.12 (95% CI, -0.56 to 0.80) for the SF-12 mental component score. In contrast, the hazard rate of all-cause mortality (up to 7 years) associated with participating in CR was 0.59 (95% CI, 0.46-0.75).Conclusions and relevanceIn a cohort of 4929 patients with AMI, we found that those who did and did not participate in CR had similar reported health status during the year following AMI; however, participation in CR did confer a significant survival benefit. These findings underscore the need for increased use of validated patient-reported outcome measures to further examine if and how health status can be maximized for patients who participate in CR.

Project description:ObjectiveTo compare the effect of home based and supervised centre based cardiac rehabilitation on mortality and morbidity, health related quality of life, and modifiable cardiac risk factors in patients with coronary heart disease.DesignSystematic review.Data sourcesCochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, Medline, Embase, CINAHL, and PsycINFO, without language restriction, searched from 2001 to January 2008.Review methodsReference lists checked and advice sought from authors. Included randomised controlled trials that compared centre based cardiac rehabilitation with home based programmes in adults with acute myocardial infarction, angina, or heart failure or who had undergone coronary revascularisation. Two reviewers independently assessed the eligibility of the identified trials and extracted data independently. Authors were contacted when possible to obtain missing information.Results12 studies (1938 participants) were included. Most studies recruited patients with a low risk of further events after myocardial infarction or revascularisation. No difference was seen between home based and centre based cardiac rehabilitation in terms of mortality (relative risk 1.31, 95% confidence interval 0.65 to 2.66), cardiac events, exercise capacity (standardised mean difference -0.11, -0.35 to 0.13), modifiable risk factors (weighted mean difference systolic blood pressure (0.58 mm Hg, -3.29 mm Hg to 4.44 mm Hg), total cholesterol (-0.13 mmol/l, -0.31 mmol/l to 0.05 mmol/l), low density lipoprotein cholesterol (-0.15 mmol/l, -0.31 mmol/l to 0.01 mmol/l), or relative risk for proportion of smokers at follow-up (0.98, 0.73 to 1.31)), or health related quality of life, with the exception of high density lipoprotein cholesterol (-0.06, -0.11 to -0.02) mmol/l). In the home based participants, there was evidence of superior adherence. No consistent difference was seen in the healthcare costs of the two forms of cardiac rehabilitation.ConclusionsHome and centre based forms of cardiac rehabilitation seem to be equally effective in improving clinical and health related quality of life outcomes in patients with a low risk of further events after myocardial infarction or revascularisation. This finding, together with the absence of evidence of differences in patients' adherence and healthcare costs between the two approaches, supports the further provision of evidence based, home based cardiac rehabilitation programmes such as the "Heart Manual." The choice of participating in a more traditional supervised centre based or evidence based home based programme should reflect the preference of the individual patient.

Dataset Information

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial.

Publications

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial.

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