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Clinical Trials/NCT06473532
NCT06473532
Recruiting
Not Applicable

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

University of Illinois at Chicago1 site in 1 country30 target enrollmentSeptember 26, 2024
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Illinois at Chicago
Enrollment
30
Locations
1
Primary Endpoint
Change in Self-care Symptom Perception
Status
Recruiting
Last Updated
7 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 26, 2024
End Date
June 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan W. Leigh

PhD Candidate

University of Illinois at Chicago

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

Outcomes

Primary Outcomes

Change in Self-care Symptom Perception

Time Frame: Baseline, 4 weeks, 12 weeks

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.

Change in Self-care self-management

Time Frame: Baseline, 4 weeks, 12 weeks

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.

Change in Self-Care Maintenance

Time Frame: Baseline, 4 weeks, 12 weeks

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.

Secondary Outcomes

  • 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)
  • Medication and Refill adherence(Baseline, 4 weeks, 12 weeks)
  • Heart Healthy Diet Adherence(Baseline, 4 weeks, 12 weeks)
  • Heart Failure Quality of Life(Baseline, 4 weeks, 12 weeks)

Study Sites (1)

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