Cardiology · Medical Literature
Tailored Text Messaging Intervention to Improve Self-Care in Patients With Heart Failure (Text4HF): Protocol for a Pilot Randomized Controlled Trial.
Abstract
Heart failure (HF) is a major public health problem associated with frequent hospitalizations, high mortality, and substantial health care costs. Self-care is fundamental to improving health outcomes; yet, self-care is commonly poor among patients with HF. SMS text messaging interventions may provide a simple, scalable, and accessible strategy to support HF self-care, particularly among older adults who may face barriers to using more complex digital health technologies. However, the efficacy of text messaging as a standalone intervention for patients with HF remains underexplored. This protocol paper describes the rationale and design of a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of an individually Tailored Text Messaging Intervention to Improve Self-Care in Adults with HF (Text4HF). This study is a single-site, stage I, parallel-group randomized controlled trial. Participants (n=30) are community-dwelling adults aged 50 years or older with stage C HF and suboptimal self-care, defined as a score of 3 or less on at least 2 items of the Self-Care of Heart Failure Index (SCHFI v7.2). Participants are randomized (1:1) to either a 12-week tailored text messaging intervention (Text4HF) plus usual care or usual care alone. Text messages are triggered based on patient responses to validated instruments assessing evidence-based, modifiable behavioral factors of HF self-care. Feasibility (recruitment and retention) and acceptability of the intervention are assessed as key process outcomes. The main exploratory patient-reported outcome is HF self-care (SCHFI v7.2). Other patient-reported outcomes include medication adherence, adherence to a heart-healthy diet, HF knowledge, health-related quality of life, self-efficacy, and health beliefs. This study was funded in June 2022, and participant recruitment began in September 2024. A total of 26 participants have been enrolled and randomized to the intervention (n=13) and control (n=13) groups. Participants have a mean age of 60 (SD 6.6) years, 46% (12/26) are female, and 73% (19/26) identify as non-Hispanic Black. Half of the participants are individuals with reduced ejection fraction. Study completion is anticipated in June 2026. This protocol describes an important step toward evaluating a scalable, low-cost text messaging intervention designed to improve self-care in patients with HF. Study findings will provide critical data on feasibility and acceptability to guide a future fully powered efficacy trial of Text4HF.
Clinical relevance
Heart failure remains a major public health burden characterized by frequent hospitalizations, high mortality, and substantial healthcare costs, with suboptimal self-care being a key modifiable driver of poor outcomes. This trial addresses a critical evidence gap by evaluating SMS-based text messaging as a standalone, scalable digital health intervention to improve HF self-care, particularly in older, community-dwelling adults who may face barriers to more complex digital platforms. Given the disproportionate representation of non-Hispanic Black participants (73%) and those with reduced ejection fraction (50%), findings will have direct relevance to historically underserved populations at highest HF risk.
Key findings
1. This is a single-site, stage I, parallel-group pilot RCT with a target enrollment of 30 community-dwelling adults aged ≥50 years with stage C HF, randomized 1:1 to a 12-week tailored SMS intervention (Text4HF) plus usual care versus usual care alone. 2. Eligibility requires documented suboptimal HF self-care, defined operationally as a score ≤3 on at least 2 items of the validated Self-Care of Heart Failure Index (SCHFI v7.2), ensuring enrollment of a clinically meaningful high-risk cohort. 3. As of the protocol publication, 26 of 30 participants have been enrolled and randomized (intervention n=13; control n=13), with a mean age of 60 years (SD 6.6), 46% female, 73% non-Hispanic Black, and 50% with heart failure with reduced ejection fraction (HFrEF). 4. Text messages are algorithmically triggered by patient responses to validated instruments assessing evidence-based, modifiable behavioral determinants of HF self-care, representing an individually tailored (rather than generic broadcast) mHealth approach. 5. Primary outcomes are process-oriented — feasibility (recruitment and retention rates) and acceptability — with the SCHFI v7.2 designated as the main exploratory patient-reported outcome; secondary outcomes include medication adherence, heart-healthy diet adherence, HF knowledge, health-related quality of life, self-efficacy, and health beliefs. 6. Quantitative efficacy estimates (effect sizes, confidence intervals, p-values, NNT) are not yet reported, as study completion is anticipated in June 2026; this is a protocol paper and no outcome data are available.
Practice implications
Clinicians managing HF patients aged ≥50 with documented self-care deficits — particularly in medication adherence, dietary compliance, and symptom monitoring — should recognize tailored SMS interventions as a low-cost, accessible adjunct to usual care that warrants integration into future care pathways pending efficacy data. Patient selection should prioritize those with suboptimal self-care scores on a validated instrument (e.g., SCHFI) and those who may be poor candidates for more complex digital health tools, including older adults and those from underserved communities with limited smartphone or app literacy. Results from this pilot will be pivotal in determining feasibility benchmarks and effect size estimates needed to power a definitive efficacy RCT, and clinicians should monitor this trial's outcomes as a potential basis for incorporating structured text messaging programs into HF disease management protocols.