Key result
This protocol describes a planned 30-patient pilot randomized controlled trial to evaluate the feasibility and preliminary efficacy of a tailored text messaging intervention for heart failure self-care.
Why the study?
Self-care adherence is poor among middle-aged and older adults with HF, creating a critical need for effective interventions targeting modifiable behavioral risk factors.
Does an individually tailored text messaging intervention improve self-care in middle-aged and older adults with heart failure?
RCT (n=30)
1:1
No
Does an individually tailored text messaging intervention improve self-care in middle-aged and older adults with heart failure?
This protocol outlines a pilot randomized controlled trial to evaluate the feasibility and preliminary efficacy of a tailored text messaging intervention for improving self-care in heart failure patients.
Protocol for pilot RCT of tailored texting in HF; leaves open feasibility and efficacy until trial completion.
BACKGROUND Heart failure (HF) is a serious chronic condition and is one of the most common hospital discharge diagnosis among adults in the United States. Self-care adherence is poor among middle aged and older adults with HF. Effective interventions targeting modifiable behavioral risk factors are critically needed given the increasing prevalence and worsened outcomes for patients with HF. Text4HF is a pilot study guided by the situation specific theory of HF self-care. The objective is to evaluate the feasibility and preliminary efficacy of an individually tailored text messaging intervention promoting self-care among middle aged and older adults with HF. OBJECTIVE This protocol aims to describe a randomized controlled trial designed to evaluate the feasibility and preliminary efficacy of individually tailored text messages on heart failure self-care. METHODS A single site, prospective, two-arm randomized controlled trial will be conducted. Participants (n= 30) will be recruited and randomized (1:1) to the intervention (Text4HF) or control group (usual care). The intervention group will receive 5 text messages per week for 12 weeks. Text message content reflects behavior consistent with adequate HF self-care such as medication adherence, heart healthy diet, HF symptoms self-monitoring, and self-efficacy in addition to usual care. The primary outcome is HF self-care, assessed with the Self-care Heart Failure Index (SCHFI v7.2). Feasibility (recruitment and retention) will be assessed over 12 weeks. Secondary outcomes include medication adherence, heart healthy diet adherence, HF knowledge, health related quality of life, self-efficacy, and health beliefs. RESULTS The trial was registered in June 2024. Recruitment is currently underway and began in September 2024 to the present, with 23 participants enrolled. Data collection will continue until early 2026. Results are expected to be published by the end of 2026. CONCLUSIONS This study represents a crucial step in testing a potentially scalable and low-cost intervention that can augment usual care to improve self-care among adults (≥50 years) with HF. CLINICALTRIAL NCT06473532
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Leigh et al. (2026) conducted an RCT in Heart failure (n=30). Text4HF (individually tailored text messaging intervention) vs. Usual care was evaluated on Heart failure self-care (assessed with SCHFI v7.2) and feasibility (recruitment and retention). This protocol describes a planned 30-patient pilot randomized controlled trial to evaluate the feasibility and preliminary efficacy of a tailored text messaging intervention for heart failure self-care.
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