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Randomized Controlled Trial
. 2015 Sep;21(9):719-29.
doi: 10.1016/j.cardfail.2015.05.012. Epub 2015 May 29.

Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes

Sandra B Dunbar  1 , Carolyn M Reilly  2 , Rebecca Gary  2 , Melinda K Higgins  2 , Steven Culler  3 , Brittany Butts  2 , Javed Butler  4
Affiliations
Randomized Controlled Trial

Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes

Sandra B Dunbar et al. J Card Fail. 2015 Sep.

Abstract

Objectives: Persons with concomitant heart failure (HF) and diabetes mellitus (DM) have complicated, often competing, self-care expectations and treatment regimens that may reduce quality of life (QOL). This randomized controlled trial tested an integrated self-care intervention on outcomes of HF and DM QOL, physical function, and physical activity (PA).

Methods and results: Participants with HF and DM (n = 134; mean age 57.4 ± 11 years, 66% men, 69% minority) were randomized to usual care (control) or intervention. The control group received standard HF and DM educational brochures with follow-up telephone contact. The intervention group received education and counseling on combined HF and DM self-care (diet, medications, self-monitoring, symptoms, and PA) with follow-up home visit and telephone counseling. Measures included questionnaires for HF- and DM-specific and overall QOL, PA frequency, and physical function (6-min walk test [6MWT]) and were obtained at baseline and 3 and 6 months. Analysis included mixed models with a priori post hoc tests. Adjusting for age, body mass index, and comorbidity, the intervention group improved in HF total (P = .002) and physical (P < .001) QOL scores at 3 months with retention of improvements at 6 months, improved in emotional QOL scores compared with control at 3 months (P = .04), and improved in health status ratings (P = .04) at 6 months compared with baseline. The intervention group improved in 6MWT distance (924 ft to 952 ft; P = .03) whereas the control group declined (834 ft to 775 ft; F1,63 = 6.86; P = .01). The intervention group increased self-reported PA between baseline and 6 months (P = .01).

Conclusions: An integrated HF and DM self-care intervention improved perceived HF and general QOL but not DM QOL. Improved physical functioning and self-reported PA were also observed with the integrated self-care intervention. Further study of the HF and DM integrated self-care intervention on other outcomes, such as hospitalization and cost, is warranted.

Trial registration: ClinicalTrials.gov NCT01606085.

Keywords: Heart failure; diabetes; intervention; quality of life; self-care.

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Figures

Figure 1
Figure 1
QUALITY HF-DM Consort Flowchart
Figure 2
Figure 2
Minnesota Living with HF Questionnaire (MLHFQ) Scores over time by group. Means and 95% Confidence Intervals for Total, Physical and Emotional scores (adjusted for Age, BMI and CCI). a. MLHFQ Total: Adjusted Means and 95% CI (for Age, BMI, CCI) b. MLHFQ Physical: Adjusted Means and 95% CI (for Age, BMI, CCI) c. MLHFQ Emotional: Adjusted Means and 95% CI (for Age, BMI, CCI)
Figure 2
Figure 2
Minnesota Living with HF Questionnaire (MLHFQ) Scores over time by group. Means and 95% Confidence Intervals for Total, Physical and Emotional scores (adjusted for Age, BMI and CCI). a. MLHFQ Total: Adjusted Means and 95% CI (for Age, BMI, CCI) b. MLHFQ Physical: Adjusted Means and 95% CI (for Age, BMI, CCI) c. MLHFQ Emotional: Adjusted Means and 95% CI (for Age, BMI, CCI)
Figure 2
Figure 2
Minnesota Living with HF Questionnaire (MLHFQ) Scores over time by group. Means and 95% Confidence Intervals for Total, Physical and Emotional scores (adjusted for Age, BMI and CCI). a. MLHFQ Total: Adjusted Means and 95% CI (for Age, BMI, CCI) b. MLHFQ Physical: Adjusted Means and 95% CI (for Age, BMI, CCI) c. MLHFQ Emotional: Adjusted Means and 95% CI (for Age, BMI, CCI)
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