Effect of behavioral management on quality of life in mild heart failure: a randomized controlled trial

https://doi.org/10.1016/j.pec.2004.06.007Get rights and content

Abstract

There has been a lack of research regarding nonpharmacologic interventions in heart failure. The objective was to determine the effect of behavioral management on health related quality of life (HRQL) in patients with heart failure. Participants (N = 116) were randomly assigned to one of two groups: usual care for heart failure (n = 58) and the 15-week behavioral management program (n = 58). Outcomes included exercise performance (6-min walk), physical and mental functioning (SF-36), general health perceptions (SF-36), and disease specific HRQL (Minnesota Living with Heart Failure Questionnaire—MLHF). Outcomes were assessed at baseline, 4, 10 and 16 months. Participants were mostly male (95%) and Caucasian (75%), with a mean age of 67 years (S.D. = 10). Intervention patients showed significantly improved self-reported disease specific HRQL (MLHF physical dimension scores) over time compared to control patients. There were no group differences in exercise performance, physical functioning, mental functioning or general health perceptions.

Introduction

It is well known that heart failure is a significant and growing health care problem with high mortality, reduced quality of life and significant economic burden on society [1]. Patient management and guideline recommendations include encouraging patients to be more active in their own care, patient and family education, symptom management, exercise training, dietary modification, and adherence to the prescribed medications [1], [2], [3]. Behavioral self-management in patients with heart failure may help to control symptoms, maintain function, avoid preventable re-hospitalization, and ultimately decrease morbidity and mortality. One desired outcome from behavioral self-management is enhanced health related quality of life (HRQL); however, only a few groups have reported behavioral interventions specific to heart failure [4], [5]. Evaluation of behavioral interventions is still lacking and interventions to improve HRQL in patients with heart failure still need to be tested. The primary objective of this study was to determine the effect of a nurse-led behavioral management intervention on HRQL in patients with mild heart failure. It was hypothesized that patients who participated in a nurse-led behavioral management intervention as compared to usual care over a 16-month follow-up period (baseline, 4, 10, and 16 months) would have improved exercise performance, physical functioning, mental functioning, and general health perceptions.

Section snippets

General design

This was a randomized clinical trial design (Fig. 1). Following eligibility screening and consent, 116 patients were randomly assigned to one of two treatment groups to evaluate the clinical impact of the intervention. A stratified blocked randomization approach based on the Specific Activity Scale (SAS) was used to assure that patients were equally distributed based on functional performance. The control group received usual care for patients with heart failure (n = 58). The intervention group

Patient characteristics

A total of 116 patients enrolled in the study. Participants were primarily male (n = 110, 95%), reflecting the VA population, and Caucasian (n = 87, 75%). The mean age of the entire sample was 67 years (S.D. = 10); ages ranged from 41 to 90 years. The median ejection fraction for both groups was 40%; these data were available in 69 (60%) of the participants from the total sample. Heart failure etiology was available for 88 (76%) of the 116 participants. The most frequently reported etiologies

Discussion

The important results from this study are in the domain of physical functioning. The physical functioning measures included an objective measurement of exercise performance (the 6-min walk) and a self-report measure of impairment due to heart failure (MLHF physical functioning score). The MLHF self-report measure demonstrated a better outcome in the participants randomized to the behavioral management intervention compared to the control group. The 6-min walk was significantly better only with

Conclusions and practice implications

This study demonstrates efficacy of the behavioral management intervention on a self-reported disease specific physical functioning. This study is unique in that it focused on HRQL as a primary patient outcome, used both generic and disease-specific questionnaires for measuring HRQL, tracked HRQL longitudinally, and examined optimal timing of the behavioral management intervention, as well as measurements to evaluate the intervention. The major practice implication suggested by this study is

Acknowledgements

We gratefully acknowledge the work of research associates Debbie Dugan, MS, RN, Malinda Fox, MS, RN, Joan Hall, MS, RN, Mary Jane Hoban, MS, RN, Lien Khuat, MS, RN, Vicki McCalmont, MS, RN, Kimberly Newell, MS, RN, Beth Schanke, MS, RN; database management specialist Jo-Anne Toomey, MBA; quality control consultant Ann Bryant, MS, RN; data review board members Kirk Peterson, MD, Barbara Riegel, DNSc, RN; intervention advisors Sheri Pruitt, PhD and Allen Gifford, MD; and general support of the VA

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