Currently accepted at: JMIR mHealth and uHealth
Date Submitted: Mar 18, 2025
Date Accepted: Dec 19, 2025
Date Submitted to PubMed: Dec 22, 2025
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/74121
The final accepted version (not copyedited yet) is in this tab.
An "ahead-of-print" version has been submitted to Pubmed, see PMID: 41428504
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The ManageHF Just-in-Time Adaptive Mobile Application Interventions to Promote Self-Management and Improve Outcomes in Heart Failure: A Randomized Controlled Trial
ABSTRACT
Background:
Heart failure (HF) is a major healthcare 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 excess, can reduce quality of life and precipitate hospital admissions. Existing mHealth approaches to HF self-management have produced mixed results, highlighting the need for innovative strategies to improve post-discharge outcomes in at-risk patients.
Objective:
The ManageHF trial aimed to evaluate the effectiveness of two just-in-time adaptive interventions (JITAIs) delivered via a mobile application to enhance HF self-management. The interventions focused on symptom recognition and lower dietary sodium restriction, with the goal of reducing readmissions and improving HRQOL over a 12-week period.
Methods:
The trial was a 2x2 factorial, double-blind, randomized controlled study conducted across several U.S. institutions. Participants recently hospitalized for acute HF were randomized into four 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 Heart Failure Questionnaire (MLHFQ).
Results:
Recruitment was challenged by the COVID-19 pandemic, leading to early trial discontinuation. Of 62 participants enrolled, 43 completed the study. Participants were diverse, with a mean age of 55 years; 32% were female, and 55% were Black or African American. Most had HF with reduced ejection fraction. While the interventions did not significantly improve outcomes, they showed a numerically favorable trend in improving the composite endpoint compared to controls. However, due to the early termination and small sample size, the ability to detect statistically significant differences was limited.
Conclusions:
The ManageHF trial highlighted the potential of mobile health technology to support HF management, particularly in enhancing HRQOL. Despite the early termination, the interventions showed promising trends toward clinical benefit. Future studies employing more effective recruitment and retention strategies are crucial for establishing the efficacy of these interventions with greater certainty. Clinical Trial: NCT04755816
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