TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure

NCT ID: NCT06473532

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2026-06-30

Brief Summary

The goal of this study is to determine whether an individually tailored text messaging intervention can improve self-care in older adult patients with heart failure. The main question it aims to answer are:

• Is a tailored text messaging intervention feasible and acceptable among older adult patients with heart failure?
• Does tailored text messaging improve self-care in adult patients with heart failure?

Participants will be randomly assigned to one of two groups for 12 weeks: 1) intervention (text messaging); or 2) control group. Both groups will receive usual care, which includes regular follow-up visits at the heart failure clinic (standard care), plus a "Discharge Packet for Patients Diagnosed with Heart Failure", developed by the American Heart Association. Both groups will be asked via text messages and/or telephone calls to complete questionnaires at baseline/start, 4 weeks and 12 weeks, about self-care, quality of life, health beliefs, medications, diet, etc.

Participants assigned to the intervention group will also receive approximately 5 text messages/week targeting medication adherence, heart-healthy diet, and self-monitoring for 12 weeks.

Detailed Description

Heart failure (HF) is a serious chronic condition and the most common hospital discharge diagnosis among older adults in the United States. Almost 7 million Americans are diagnosed with HF and new cases are rapidly rising at a rate of nearly 1 million per year. This feasibility pilot randomized controlled trial will be conducted using individually tailored text message (TM) intervention, delivered to improve HF self-care adherence.

This randomized controlled trial in older adult patients (≥50 years of age) with HF to determine the feasibility (recruitment capability, acceptability), and preliminary efficacy of the Text4HF intervention compared with usual care over 12 weeks. Thirty (n=30) adult patients from the University of Illinois Hospital & Health Sciences System (UIH) will be randomly assigned to the intervention or usual care group. Patients in the TM intervention (TEXT4HF) will receive messages that target the most common self-care factors known to precipitate HF hospitalizations (medication adherence, heart-healthy diet, and self-monitoring).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEXT4HF

In addition to usual care and a standard AHA information packet for patients with HF, participants in the intervention group will receive 5 tailored TMs/week for 12 weeks, targeting health beliefs about medication adherence, heart-healthy diet, self-monitoring, and heart failure knowledge.

Group Type: EXPERIMENTAL

TEXT4HF

Intervention Type: BEHAVIORAL

In addition to usual care, participants in the intervention group will receive 5 TMs/week for 12 weeks at a time of their preference. Tailoring of the TMs is performed based on participants' responses to validated questionnaires (health beliefs scales, HF-knowledge scale, and self-efficacy about HF self-care scale), administered at baseline and 4 weeks. They will also receive an AHA HF discharge informational packet.

Control Group

The control group will receive standard HF medical care, which includes nurse-led patient education about HF self-care before and/or after discharge as well as follow-up visits at the Outpatient Heart Failure Clinic at UIH post-hospital discharge and several times per year or more, depending on the severity of the patient's condition. Participants will also receive the AHA information packet for patients with HF.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEXT4HF

In addition to usual care, participants in the intervention group will receive 5 TMs/week for 12 weeks at a time of their preference. Tailoring of the TMs is performed based on participants' responses to validated questionnaires (health beliefs scales, HF-knowledge scale, and self-efficacy about HF self-care scale), administered at baseline and 4 weeks. They will also receive an AHA HF discharge informational packet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥50 years of Age
• HF Stage C, NYHA Class I-IV and on a loop diuretic
• Own a Mobile phone with Text message plan
• Ability to speak and read English
• Suboptimal HF self-care. (SCHFI Score of 3 or less in at least 2 items of any subscale: Self-care maintenance, Symptom Perception, or Self-management)

Exclusion Criteria

• SAVR/TAVR or Ventricular Assist Device, or Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) scheduled within the next 3 months
• Coronary revascularization, and/or CRT-implantation within the last 30 days (EMR Review)
• Psychosis
• Hospice or End-of-life care
• Advanced Renal disease (i.e., estimated Glomerular Filtration Rate <25 or Hemodialysis)
• Cognitive impairment (i.e., Dementia, Alzheimer's)
• Unable to self-manage (take medication, bathe, use the toilet, etc.)
• Currently living in a nursing home

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Jonathan W. Leigh

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan W Leigh, MPH, MSHI

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Spyros Kitsiou, PhD

Role: STUDY_CHAIR

University of Illinois Chicago

Locations

University of Illinois, Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan W Leigh, MPH, MSHI

Role: CONTACT

leighj@uic.edu

312-355-3261

Spyros Kitsiou, PhD

Role: CONTACT

skitsiou@uic.edu

Facility Contacts

Jonathan W Leigh, MPH, MSHI

Role: primary

leighj@uic.edu

312-355-3261

Spyros Kitsiou, PhD

Role: backup

skitsiou@uic.edu

312-355-3519

Other Identifiers

2022-0704

Identifier Type: -

Identifier Source: org_study_id