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

NCT06473532 | Recruiting

• 1 other identifier: 2022-0704
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; mHealth; Text Messaging; Mobile Phone

Outcome Measures

Primary Outcomes (3)

• Change in Self-Care Maintenance

  Self-care maintenance will be measured with Subscale A of the Self-Care Heart Failure Index (SCHFI) v.7.2, which includes 10-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.

  Baseline, 4 weeks, 12 weeks

• Change in Self-care Symptom Perception

  Self-care symptom perception will be measured the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale B, which includes 9-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.

  Baseline, 4 weeks, 12 weeks

• Change in Self-care self-management

  Self-care self-management will be measured with the Self-Care Heart Failure Index (SCHFI) v.7.2, Subscale C, which includes 8-items. Standardized scores in this scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.

  Baseline, 4 weeks, 12 weeks

Secondary Outcomes (8)

• Health Beliefs about Medication Compliance

  Baseline, 4 weeks, 12 weeks

• Health Beliefs about Dietary Compliance

  Baseline, 4 weeks, 12 weeks

• Health Beliefs about Self-Monitoring Compliance

  Baseline, 4 weeks, 12 weeks

• Heart Failure knowledge

  Baseline, 4 weeks, 12 weeks

• Change in Self-care confidence (self-efficacy)

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

TEXT4HF

EXPERIMENTAL

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.

Behavioral: TEXT4HF

Control Group

NO INTERVENTION

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.

Interventions

TEXT4HF 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.

TEXT4HF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jonathan W Leigh, MPH, MSHI

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

• Spyros Kitsiou, PhD

  University of Illinois Chicago

  STUDY CHAIR

Central Study Contacts

Jonathan W Leigh, MPH, MSHI

CONTACT

312-355-3261; leighj@uic.edu

Spyros Kitsiou, PhD

CONTACT

skitsiou@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: September 26, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)