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Habits heart app for patient engagement in heart failure management: pilot feasibility randomized trial
Wei KS, Ibrahim NE, Kumar AA, Jena S, Chew V, Depa M, Mayanil N, Kvedar JC, Gaggin HK
JMIR MHealth and UHealth 2021 Jan;9(1):e19465
clinical trial
2/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Due to the complexity and chronicity of heart failure, engaging yet simple patient self-management tools are needed. OBJECTIVE: This study aimed to assess the feasibility and patient engagement with a smartphone app designed for heart failure. METHODS: Patients with heart failure were randomized to intervention (smartphone with the Habits Heart App installed and Bluetooth-linked scale) or control (paper education material) groups. All intervention group patients were interviewed and monitored closely for app feasibility while receiving standard of care heart failure management by cardiologists. The Atlanta Heart Failure Knowledge Test, a quality of life survey (Kansas City Cardiomyopathy Questionnaire), and weight were assessed at baseline and final visits. RESULTS: Patients (N = 28 patients; intervention: n = 15; control: n = 13) with heart failure (with reduced ejection fraction 15/28, 54%; male 20/28, 71%, female 8/28, 29%; median age 63 years) were enrolled, and 82% of patients (N = 23; intervention 12/15, 80%; control 11/13, 85%) completed both baseline and final visits (median follow up 60 days). In the intervention group, 2 out of the 12 patients who completed the study did not use the app after study onboarding due to illnesses and hospitalizations. Of the remaining 10 patients who used the app, 5 patients logged >= 1 interaction with the app per day on average, and 2 patients logged an interaction with the app every other day on average. The intervention group averaged 403 screen views (per patient) in 56 distinct sessions, 5-minute session durations, and 22 weight entries per patient. There was a direct correlation between duration of app use and improvement in heart failure knowledge (Atlanta Heart Failure Knowledge Test score; rho = 0.59, p = 0.04) and quality of life (Kansas City Cardiomyopathy Questionnaire score; rho = 0.63, p = 0.03). The correlation between app use and weight change was rho = -0.40 (p = 0.19). Only 1 out of 11 patients in the control group retained education material by the follow-up visit. CONCLUSIONS: The Habits Heart App with a Bluetooth-linked scale is a feasible way to engage patients in heart failure management, and barriers to app engagement were identified. A larger multicenter study may be warranted to evaluate the effectiveness of the app. TRIAL REGISTRATION: ClinicalTrials.gov NCT03238729; http://ClinicalTrials.gov/ct2/show/NCT03238729.

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