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Effects of a home-based activation intervention on self-management adherence and readmission in rural heart failure patients: the PATCH randomized controlled trial |
Young L, Hertzog M, Barnason S |
BMC Cardiovascular Disorders 2016 Sep 8;16(176):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Heart failure (HF) patients discharged from rural hospitals have higher 30-day readmission rates. Self-management (SM) reduces readmissions, but adherence to SM guidelines is low in the rural HF population. We tested a home-based intervention to enhance patient activation and lead to improved SM adherence. METHODS: In this two-group, repeated measures randomized control trial, the main outcomes were patient reported and clinical outcomes associated with SM adherence, and all-cause readmission at 30, 90 and 180 days. RESULTS: The study included 100 HF patients discharged from a rural critical access hospital. The intervention group received a 12-week SM training and coaching program delivered by telephone and tailored on subjects' activation levels. At alpha 0.10, the PATCH intervention showed significantly greater improvement compared to usual care in patient-reported SM adherence: weighing themselves, following a low-sodium diet, taking prescribed medication, and exercising daily (all p < 0.0005) at 3 and 6 months after discharge. In contrast, groups did not differ in physical activity assessed by actigraphy or in clinical biomarkers. Contrary to expectation, the 30-day readmission rate was significantly higher (p = 0.088) in the intervention group (19.6%) than in the control group (6.1%), with no differences at 90 or 180 days. CONCLUSION: It is feasible to conduct a randomized controlled trial in HF patients discharged from rural critical access hospitals. Significantly higher patient-reported SM adherence was not accompanied by lower clinical biomarkers or readmission rates. Further research is needed to understand mechanisms that influence outcomes and healthcare utilization in this population. TRIAL REGISTRATION: Clinical trial registration information ClinicalTrials.gov NCT01964053.
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