Objectives: In the Quality HF-DM trial, which tested an integrated self-care intervention for persons with heart failure (HF) and diabetes (DM), improved perceived HF and general health-related quality of life (QOL) and physical functioning were observed, but not for DM QOL. However, some participants did improve. This analysis examined the demographic and clinical factors associated with positive and clinically meaningful change in outcomes in response to the intervention to help inform future improvement in targeted interventions.
Methods: HF-DM participants (n=134), mean age 57.4 ± 11 years, 66% men, 69% African American, were randomized to usual care (UC) or intervention (INT) with assessments at baseline (BL), 1, 3 and 6 months (M). Intervention included education/counseling focused on HF-DM self-care. Variables (measures, clinically meaningful change between BL-6 M) were: HF QOL (MLHFQ >5), general QOL (EQ5D-index >0.1; EQ5D-VAS >10), DM QOL (ADDQOL, >1), physical function (6 Minute Walk Test [6MWT] >50 meters). Age, gender, race, education, living arrangements, NYHA class and time with HF and DM were evaluated after adjusting for the INT group using linear and logistic regression to assess for relationship to improvements in outcomes.
Results: For general QOL EQ5D index scores, those with less education (high school or less) (p=.024); those with NYHA class 3 or 4 (p=.036); and those with DM longer (p=.011) improved more. For MLWHF scores, whites were more likely than African Americans to improve their MLWHF scores (p=.05). For DM QOL (ADDQOL), 35% of younger participants (<=58 yrs.) in the intervention group improved their ADDQOL scores by 1 or more points compared to only 10% of the older participants (>58 yrs.) (p=.039). For 6MWT distances, males in INT group more likely to achieve improvement (p=.014), and those with NYHA class 3 or 4 more likely to improve (p=.048).
Conclusions: When considering QOL and physical function outcomes in response to an HF-DM self-care intervention, age, education, race, gender, NYHA class, and time with DM were important. The INT improved outcomes in vulnerable groups of lower education, greater HF severity, and longer times with DM. Effects differed by EQ5D, MLWHF and ADDQOL measures highlighting the importance of evaluating multiple general and disease specific QOL dimensions, and the need to consider demographic and clinical risk factors to tailor toward more precise interventions.