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Completed

NCT Number: NCT06473532

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Health Beliefs about Medication Compliance

    Time frame: Baseline, 4 weeks, 12 weeks

    Beliefs about Medication Compliance Scale (12-items)The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 6-30. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.

  2. Health Beliefs about Dietary Compliance

    Time frame: Baseline, 4 weeks, 12 weeks

    Beliefs about Dietary Compliance Scale (12 items)The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 6-30. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.

  3. Health Beliefs about Self-Monitoring Compliance

    Time frame: Baseline, 4 weeks, 12 weeks

    Beliefs about Self-Monitoring Scale (18 items). The instrument uses a 5-point Likert scale. Benefits and Barriers scores range from 18-90. Lower Barrier scores indicate a better outcome. Higher Benefits scores indicate a better outcome.

  4. Heart Failure knowledge

    Time frame: Baseline, 4 weeks, 12 weeks

    Atlanta Heart Failure Knowledge Questionnaire (30-items). Scored range is 0 to 30 with higher scored indicating better knowledge about heart failure.

  5. Change in Self-care confidence (self-efficacy)

    Time frame: Baseline, 4 weeks, 12 weeks

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

  6. Medication and Refill adherence

    Time frame: Baseline, 4 weeks, 12 weeks

    Assessed with Adherence to Refilling Medication Scale (ARMS); 12 Items, 4-point Likert scale, lower scores indicate better adherence

  7. Heart Healthy Diet Adherence

    Time frame: Baseline, 4 weeks, 12 weeks

    Assessed with Scale for Dietary Behaviors in Heart Failure (SDBHF); 19 Items, 4-point Likert scale, higher scores indicate better adherence

  8. Heart Failure Quality of Life

    Time frame: Baseline, 4 weeks, 12 weeks

    Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: TEXT4HF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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