Randomized Clinical Trial of an Integrated Self-Care Intervention for Persons With Heart Failure and Diabetes: Quality of Life and Physical Functioning Outcomes

• An integrated heart failure and diabetes self-care intervention was developed, and a prospective randomized trial was conducted to compare the intervention with usual care.
• At 3 and 6 months' follow-up, the intervention group, but not the control group, had improved heart failure–related quality of life.
• In a subgroup of patients who completed 6-minute walk tests at baseline and 6 months, distances increased in the intervention group but declined in the control group.
• The intervention group reported higher physical activity levels than the control group.

ObjectivesPersons 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 ResultsParticipants 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).ConclusionsAn 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.