Heart failure (HF) is a highly prevalent chronic condition and a leading cause of hospitalization and mortality among middle-aged and older adults (≥50 y) in the United States, contributing to a growing public health burden [1,2]. An estimated 6.7 million Americans have HF, with projections expected to reach almost 9 million by 2030 [2,3]. Epidemiological data indicate that HF disproportionately affects Black people, who experience a higher prevalence (approximately 4.1% compared with 2.8% among White adults), an earlier age of onset (often by a decade), and higher rates of HF-related hospitalization and mortality compared with other racial and ethnic groups [2]. Despite advances in pharmacological and technological therapies, HF-related costs, readmissions, and mortality remain persistently high. Approximately 1 in 4 patients hospitalized for HF are readmitted within 30 days, with an average cost of US $18,000 per readmission [4-6]. These adverse outcomes place substantial strain on health care systems and increase the per capita economic burden of HF.

Evidence suggests that many hospital readmissions may be preventable if patients consistently engage in better HF self-care [7-12]. HF self-care is essential for patients with HF, and improving self-care remains a primary target of multidisciplinary HF management programs. Self-care is a dynamic, patient-centered decision-making process involving routine behaviors and actions that maintain physiological stability (self-care maintenance), facilitate symptom recognition (symptom perception), and guide responses to HF symptoms (self-care management) [13,14]. Clinical guidelines emphasize the central role of patient engagement in HF self-care to improve health outcomes [1,14]. HF self-care comprises several modifiable lifestyle behaviors, including taking medications as prescribed, following a heart-healthy diet, routinely monitoring for HF signs and symptoms (eg, edema, fatigue, and shortness of breath), and engaging regularly in physical activity [1,14]. Systematic reviews of interventions designed to improve HF self-care have demonstrated reductions in hospital readmissions and mortality, as well as improvements in health-related quality of life [9-12].

Despite these benefits, many patients struggle to adhere to guideline-directed self-care behaviors [15-18]. Prior research has identified multiple determinants of poor HF self-care that can be broadly categorized into modifiable behavioral factors and contextual factors. Modifiable behavioral factors include health beliefs, inadequate knowledge about HF and self-care [19-21], low self-efficacy [7,22], forgetfulness [23], and difficulty recognizing symptoms [21,24]. All of these factors are amenable to targeted behavioral interventions. Contextual factors such as socioeconomic and demographic disparities (eg, age, race or ethnicity, and education) as well as clinical characteristics (eg, comorbidities and HF functional status) further influence HF self-care capacity, with racial and ethnic minority populations experiencing disproportionately worse HF outcomes, including higher hospitalization and mortality rates [25]. Although nurse-led patient education and discharge counseling interventions can effectively improve HF self-care, their broader implementation and reach are often limited by reliance on in-person delivery and substantial clinical resources, including staff time and availability. Outside the clinical setting, much of the responsibility for managing HF shifts to community-dwelling patients, who must perform complex self-care behaviors daily. Therefore, there is a critical need to develop and rigorously evaluate low-cost and scalable patient-centered interventions that target evidence-based modifiable behavioral factors of HF self-care, while accounting for broader contextual influences.

Mobile Health (mHealth) technologies including consumer-facing applications and wearables have shown promise for improving HF self-care and reducing hospitalizations [26-30]. Despite this, mHealth adoption and implementation barriers remain common. Patients frequently report challenges related to older age, low digital literacy, fear of new technology, and limited internet access [31]. However, text messaging (TM), or SMS, represents an established and widely used mobile technology that is often overlooked within the broader scope of mHealth tools. Unlike application or device-based interventions, TM requires minimal technical expertise, does not depend on broadband connectivity, and can be delivered at low cost and on a large scale. These characteristics may be particularly relevant for community-dwelling adults with HF, many of whom are older and may face barriers to more complex digital platforms. In a cross-sectional survey of adults with HF (N=100) conducted at a large urban academic health system, 88% reported having an unlimited TM plan and 76% reported using TM regularly [32]. Substantial evidence supports tailoring TM in interventions targeting modifiable self-management behaviors involving chronic conditions such as diabetes [33-35], hypertension [36-38], and obesity [39-41]. In HF, minimal evidence exists of using tailoring in TM interventions [42], but these interventions commonly involve mHealth apps requiring a higher level of technical acumen. Despite promising findings, individually tailored TM interventions targeting modifiable factors influencing HF self-care remain understudied as a standalone intervention. Given the need for low-cost, accessible, and scalable strategies to improve HF self-care, we developed the Tailored Text Messaging Intervention to Improve Self-Care in Patients with HF (Text4HF) study to evaluate the efficacy of a tailored TM intervention for adults with HF.

This study aims to determine the feasibility and acceptability of the Text4HF intervention in middle-aged and older adult patients (aged ≥50 y) with HF. It also aims to explore the preliminary efficacy of the Text4HF intervention on HF self-care (primary outcome) and other secondary patient-reported outcomes such as health-related quality of life, medication adherence, heart-healthy diet, and HF knowledge. This trial will provide evidence for the development of a larger trial evaluating the effect of Text4HF on HF self-care.

The Text4HF study is a stage I, prospective, 2-arm, parallel-group, randomized controlled trial (RCT) in which middle-to-older age (≥50 y) adult patients (n=30) with HF are randomly assigned to either the control group or the Text4HF intervention group for 12 weeks [43,44]. The control group receives usual care, which comprises regular outpatient appointments at the HF clinic for the duration of the study. The intervention group, in addition to usual care, receives a program of individually tailored TM for 12 weeks, targeting modifiable behaviors that influence HF self-care. The follow-up period for the study is 12 weeks, with assessments occurring at baseline, 4 weeks, and 12 weeks. Figure 1 depicts the study flow of participants: (1) eligibility screening, (2) informed consent, (3) baseline assessment, (4) randomization, (5) 4-week assessment, and (6) 12-week assessment. This protocol is reported in accordance with the Spirit guidelines (see appendix 2) [45].

This study enrolls patients with stage C HF who demonstrate suboptimal HF self-care. The eligibility criteria are summarized in Textbox 1. Participants are recruited from the University of Illinois Hospital and Health Sciences System (UI Health) in Chicago, Illinois. Potentially eligible patients are identified through the Epic electronic medical record system and are approached by trained research staff, who provide an overview of the study and assess interest in participation. Patients expressing interest undergo additional screening procedures, including the completion of the Self-Care Heart Failure Index (SCHFI) questionnaire [46]. Patients who meet all the eligibility criteria are invited to provide written informed consent prior to study enrollment.

Following the completion of baseline assessments, enrolled participants are randomized in a 1:1 ratio to either the intervention or control group (n=15 per arm). The randomization sequence is preprogrammed in REDCap (Vanderbilt University) [47] using permuted block randomization stratified by age. Allocation concealment is maintained through a secure, blinded assignment process implemented within the REDCap system. Participants are randomized sequentially in the order in which they complete the baseline assessments. To preserve the integrity of the randomization process, the REDCap system prevents any attempt to change participant assignments following allocation.

The Text4HF intervention is grounded in the Situation-Specific Theory of Heart Failure Self-Care [13] and the Health Belief Model [48,49]. Guided by these theoretical models, the intervention targets key domains of HF self-care, including self-care maintenance (eg, medication adherence and heart-healthy diet), symptom monitoring (eg, weight changes), and self-care management (eg, seeking care and adjusting diet or loop-diuretics). The TMs are designed to influence the following evidence-based mechanisms of action associated with HF self-care: health beliefs (perceived benefits and barriers regarding HF self-care) [25,50-52], self-efficacy [53-55], and HF knowledge [21,56,57]. Through these mechanisms of action, the intervention aims to improve the ability and confidence of patients with HF to engage in behaviors associated with adequate HF self-care, including medication adherence, dietary adherence, and self-monitoring behaviors. Figure 2 illustrates the conceptual framework underlying the Text4HF intervention, including the proposed mechanisms of action, targeted self-care behaviors, and study outcomes.

Details about the development of the Text4HF intervention will be reported elsewhere. Briefly, the Text4HF intervention was developed based on the Heart Messages Program [58] and the iCardia4HF intervention [42,59,60], incorporating the same evidence-based modifiable behavioral determinants of HF self-care (health beliefs, self-efficacy, and HF knowledge), validated assessment instruments, and tailoring strategies, while updating and expanding the TM library and tailoring algorithms to align with current HF clinical guidelines and to more comprehensively address medication adherence, heart-healthy diet, and symptom monitoring.

An interdisciplinary expert advisory team (n=5) with expertise in cardiology, cardiovascular nursing, behavioral TM interventions, and digital health was convened to guide the development of the intervention. The development of the TM library was guided by Kreuter’s [61] step-wise process for tailored health communication. First, the intervention target behaviors and mechanisms of action shown in the conceptual framework were identified. Second, validated instruments to assess these domains and guide message tailoring were selected. Third, we refined existing TMs from the Heart Messages and iCardia4HF intervention studies, and developed new messages informed by HF clinical guidelines [1,62], practical self-care recommendations [14], and patient education resources [63]. Fourth, new rule-based tailoring algorithms were created to link participant assessment responses to personalized TM delivery. The expert advisory team iteratively reviewed the messages to ensure clinical accuracy, behavioral relevance, and consistency with HF management recommendations. To enhance accessibility, all messages were written at approximately an eighth-grade reading level using the Flesch-Kincaid scale, consistent with recommendations for patient education materials [64]. The final TM library consisted of approximately 220 messages linked to the intervention tailoring algorithms. The following section describes the structure, content, and tailoring approach of the Text4HF intervention.

Participants allocated to the control group receive standard outpatient care through the UI Health Heart Failure Clinic. Usual care includes routine follow-up visits with the HF care team, including HF cardiologists, advanced practice nurses, and clinical pharmacists. Follow-up visits typically occur every 3 to 6 months, depending on the condition of the patient with HF. During these visits, advanced practice providers assess and titrate current HF guideline-directed medications, care providers perform clinical assessments, optimize guideline-directed medical therapy, coordinate referrals, and follow-up care (ie, primary care and cardiac rehabilitation), provide posthospitalization management, and engage in ongoing treatment planning. Participants also receive patient-centered HF self-care education based on materials developed by the American Heart Association’s Get With The Guidelines program [62].

This study uses three systems for data collection and intervention delivery: (1) REDCap, (2) Epic, and (3) iCardia. The REDCap database is used for documenting screening, enrollment, and storing intervention-related data. The Epic UI Health electronic health records system is used to abstract clinical data and document informed consent from enrolled participants. iCardia [71] is a secure, internet-based application that was developed at the university and is used to program and send TM. All data are verified, cleaned, and analyzed using SPSS (version 30.0; IBM Corp).

The study is conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization (Good Clinical Practice), and the laws and local regulations applicable in the United States. The study is approved by the Institutional Review Board (IRB protocol #2022‐0704) and is registered at ClinicalTrials.gov. Appropriate IRB waivers for electronic medical record review and research participant recruitment were granted by the University of Illinois Chicago IRB. Trained research assistants obtain informed consent using the REDCap [47] eConsent Framework once eligibility and patient interest are confirmed. Trained research assistants obtain informed consent via the REDCap [47] electronic consenting platform once eligibility and patient interest are confirmed. As part of our safety monitoring protocol, we record all hospital admissions, emergency room visits, and deaths. These events are documented in the study record by a study team member. Participants receive US $30 per study visit as compensation for their time and effort for a total of US $60 if both assessments are completed.

To protect the privacy of study participants and to maintain the confidentiality of the data, all datasets created in this study are stored electronically in secure, password-protected, and encrypted databases. All human participants are assigned a Subject ID code in REDCap, which is used during data collection throughout the study. All computerized and database systems used in this study for data collection and analysis are password-protected and encrypted, and will be accessible only to the University of Illinois Chicago key research personnel.

The findings from this trial will be disseminated at a conference as a poster or oral presentation, as well as through a manuscript that will be published in an open access, peer-reviewed journal.

Although TM has demonstrated effectiveness in self-management interventions, such as diabetes, hypertension, and obesity, evidence as a standalone study in individuals with HF is limited. Many of these studies on self-management are deployed in conjunction with remote patient monitoring. The Text4HF trial aims to address an important gap in the literature by providing preliminary evidence on the feasibility and efficacy of individually tailored text messages as a standalone intervention for improving self-care in middle-aged and older adult patients with HF. Given the potential for scalability, reach, and low cost of TM, this approach could evolve into a paradigm shift where TM could be deployed in an HF clinic. The study is not powered to establish efficacy; rather, it is intended to generate estimates of effect size and variability that will inform the design of a future fully powered RCT. We anticipate the study will demonstrate feasibility with recruitment and retention rates greater than 80%. Acceptability will be demonstrated with high rates of patient satisfaction and preliminary improvements in HF self-care compared with usual care.

In 2019, Chen et al [85] conducted a large (n=767) RCT in China that provided one-way, Heart Failure Society of America-based, educational TMs for a month to patients recently discharged from a HF-related hospitalization [40]. While the Chen et al [85] study illustrated that this approach is feasible and cost-saving, the messages were not individually tailored. iCardia4HF [42] was a complex, multicomponent mHealth intervention that included several Bluetooth-enabled devices and mobile apps, along with individually tailored TMs. The TMs created in iCardia4HF were based on the Heart Messages program [43] and focused on 3 critical domains: adherence to loop diuretics, a low-sodium diet, and self-monitoring of weight and edema. However, there is a need to further enhance and expand the existing messages. The messages should holistically address unhealthy lifestyle behaviors and ensure that the program aligns with the latest clinical guidelines for patients with HF. Additionally, it is equally important to assess the independent effect of individually tailored TMs to improve HF self-care as a standalone intervention.

Cornelius et al [86] targeted patients with HF in a small (n=30) randomized controlled pilot study involving urban patients who were provided with 2-way TM reminders to improve depression and anxiety [87]. However, TMs were used to deliver questions for the reinforcement of cognitive behavioral therapy sessions and did not include self-care related content.

The MESSAGE-HF was a large (n=699) RCT involving TM in conjunction with nurse-led telemonitoring [88]. The dose (frequency) of messages was adjusted based on the telemonitoring feedback. However, the authors reported no clinically meaningful changes in clinical laboratory levels, mortality, or hospitalizations [88].

TM is widely used and has the potential to meet the needs of patients with varying levels of technology literacy. Prior studies of TM interventions have used a one-size-fits-all approach where all patients receive a fixed dose of messages regardless of their health beliefs, knowledge of their condition, or experience with self-care. Personalization or tailoring of the messages is usually centered on including participants’ names or using other surface-level approaches. Only one other study, iCardia4HF, has used this methodology to improve self-care behavior, but it combined TM with multiple mHealth apps and connected health devices, making it difficult to assess the effects of TM as a standalone intervention [59].

The patient population demographics in the Text4HF study are approximately 80% Black or African American, 10% Hispanic or Latinx, and 10% White. This study will provide valuable data on addressing gaps in research with respect to enrolling older, low-income Black or African American patients with HF who carry the highest risk of hospitalization, morbidity, and mortality [17]. Additionally, women have traditionally been underrepresented in HF research [89-92], and this study is well-positioned to address these gaps.

The Text4HF study has the potential to address the needs of patients with HF through a simple, low-technological, yet sophisticated intervention. Improvements in patient HF self-care among patients using existing technology represent an exciting way to reach patients in the community with a low-cost solution.

This study has a few limitations. First, this is a single-site pilot study recruiting participants from an urban academic hospital setting. The population consists predominantly of patients from racial and ethnic minority groups and may not be generalizable to other demographic populations. Second, perceptions may play a role in the results because they are based on patient-reported outcomes (self-care), and the lack of blinding may contribute to performance bias. Therefore, since this is a stage I behavior change intervention, the results on the preliminary effect of the intervention on exploratory patient-reported outcomes from this study should be interpreted cautiously.

The Text4HF intervention will provide data on feasibility, acceptability, and preliminary efficacy to refine the study for a larger clinical trial in the future. Future work involving TM in HF may provide the basis for deploying this methodology into clinical practice.