JMIR Publications

ABSTRACT

Background:

Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies such as consumer-grade apps and wearable devices offer potential opportunities for patient-centered interventions to improve HF self-care, but their efficacy remains largely underexplored.

Objective:

The objective of this study was to examine the feasibility, acceptability, safety, and preliminary efficacy of a patient-centered mHealth intervention (iCardia4HF) that integrates three consumer mobile apps and devices (Heart Failure Health Storylines, Fitbit and Withings) with a program of individually tailored text messages to improve self-care among patients with chronic HF.

Methods:

We conducted a randomized controlled trial with outcome assessors masked to group assignment. Eligible patients had Stage C HF, were ≥40 years of age, and had New York Heart Association (NYHA) class I, II, or III. Patients with major cognitive impairment or on dialysis, were excluded. Patients were randomly assigned to either iCardia4HF plus usual care or to usual care only and were followed for 8 weeks. Key feasibility measures were recruitment and retention rates. The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, assessed with the Self-care Heart Failure Index (SCHFI v7.2). Key secondary outcomes were modifiable behaviors targeted by the intervention (health beliefs, self-efficacy, HF knowledge), health status, and adherence to daily self-monitoring of two core vital signs (body weight and blood pressure). Intention-to-treat analyses used repeated measures mixed-models.

Results:

A total of 27 patients were enrolled in the study and randomly assigned to iCardia4HF (n=13) or usual care (n=14). Of these 27 patients, 11 in the intervention group (iCardia4HF) and 14 in the usual care group started their assigned care and were included in the full analysis. Patients’ mean age was 56 years, 44% were female, 91% self-reported race as Black, 76% had NYHA class II or III, and 60% had HF with reduced left ventricular ejection fraction. Participant retention, completion of study visits, and adherence to using the mHealth apps and devices for daily self-monitoring was high (>80%). At 8 weeks, the mean group differences in changes in the SCHFI subscale scores consistently favored the intervention over the control group: maintenance [Cohen’s d=0.19 (-0.65, 1.02)], symptom perception [d=0.33 (-0.51, 1.17), and self-care management [d=0.25 (-0.55, 1.04)]. The greatest improvements in terms of effect size were observed in self-efficacy (d=0.68) and health beliefs about medication adherence (d=0.63) and self-monitoring adherence (d=0.94). There were no adverse events due to the intervention.

Conclusions:

iCardia4HF was found to be feasible, acceptable, and safe. A larger trial with longer follow-up duration is warranted to examine the efficacy of this patient-centered mHealth intervention among patients with HF. Clinical Trial: NCT03642275