Cardiology · Medical Literature
The ManageHF Just-in-Time Adaptive Mobile App Interventions to Promote Self-Management and Improve Outcomes in Heart Failure: Randomized Controlled Trial.
Abstract
Heart failure (HF) is a major health care challenge in the United States, with approximately 900,000 older adults hospitalized annually. Gaps in self-management, including unrecognized worsening symptoms and failure to adhere to dietary sodium restriction, can reduce quality of life and precipitate hospital admissions. Existing mobile health approaches to HF self-management have produced mixed results, highlighting the need for innovative strategies to improve postdischarge outcomes in at-risk patients. The ManageHF trial aimed to evaluate the effectiveness of 2 just-in-time adaptive interventions delivered via a mobile app to enhance HF self-management. The interventions focused on symptom recognition and lower dietary sodium restriction, with the goal of reducing readmissions and improving health-related quality of life (HRQOL) over a 12-week period. The trial was a 2×2 factorial, double-blind, randomized controlled study conducted across several US institutions. Participants recently hospitalized for acute HF were randomized into 4 groups: both interventions, either intervention alone, or an active control. The primary outcome was a composite measure assessing time to all-cause death, time to first HF readmission, and HRQOL changes, using the Minnesota Living with HF Questionnaire. Recruitment was hindered by the COVID-19 pandemic, leading to the early discontinuation of the trial. Of the 62 participants enrolled, 43 completed the study. Participants were diverse, with a mean age of 55 (SD 14.4) years, 32% (20/62) were female, and 55% (34/62) identified as Black or African American. Most had HF with reduced ejection fraction. However, due to the early termination and small sample size, the ability to detect statistically significant differences was limited. The ManageHF trial highlighted the potential of mobile health technology to support HF management, particularly in enhancing HRQOL. Future studies using more effective recruitment and retention strategies are crucial for establishing the efficacy of these interventions with greater certainty.
Clinical relevance
Heart failure affects approximately 900,000 hospitalized older adults annually in the United States, with self-management gaps in symptom recognition and dietary sodium adherence driving preventable readmissions and reduced quality of life. The ManageHF trial addresses the unmet need for scalable, personalized post-discharge digital interventions by evaluating just-in-time adaptive mobile app strategies in a high-risk, racially diverse HF population. Given the mixed evidence base for existing mHealth tools in HF, this trial is clinically timely and directly relevant to cardiologists seeking evidence-guided approaches to remote patient engagement.
Key findings
1. The trial enrolled 62 participants (43 completers) across a 2×2 factorial, double-blind RCT design, randomized to: both JITAI interventions (symptom recognition + dietary sodium restriction), either intervention alone, or active control — NOTE: due to early termination, the study was underpowered for all primary endpoints. 2. The primary composite outcome incorporated time to all-cause death, time to first HF readmission, and health-related quality of life (HRQOL) change measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ); no statistically significant between-group differences were reported, attributable to inadequate sample size. 3. The study population was notably diverse: mean age 55 (SD 14.4) years, 55% (34/62) Black or African American, and 32% (20/62) female — a demographic often underrepresented in HF mHealth trials. 4. The majority of enrolled participants had HF with reduced ejection fraction (HFrEF), defining the phenotype most likely to benefit from active self-management support in the post-discharge window. 5. Recruitment was significantly disrupted by the COVID-19 pandemic, resulting in early trial discontinuation and a final sample size far below the pre-specified power threshold, precluding definitive efficacy conclusions. 6. Despite null primary findings, the trial highlighted a signal toward HRQOL benefit with mobile app-based JITAI delivery, warranting confirmatory investigation in adequately powered future studies.
Practice implications
Clinicians should not interpret the null results of ManageHF as evidence against mHealth-based JITAI strategies for HF self-management, given the trial was substantially underpowered due to pandemic-related early termination rather than a true absence of effect. Future implementation of similar digital interventions should prioritize enrollment of post-discharge HFrEF patients — particularly underrepresented minorities — with pre-specified retention protocols and pandemic-resilient recruitment pathways to ensure adequate statistical power. Until larger confirmatory RCTs establish efficacy, mobile self-management apps focusing on symptom monitoring and sodium restriction adherence may be considered adjunctive tools in high-risk HF patients, with HRQOL (e.g., MLHFQ) serving as a validated, patient-centered primary endpoint for such trials.