TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Behavioral: TEXT4HF
- Registration Number
- NCT06473532
- Lead Sponsor
- University of Illinois at Chicago
- 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 daily HF symptoms 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 daily HF symptoms monitoring).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- ≥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)
- Heart transplant, SAVR/TAVR or Ventricular Assist Device, or Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) 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. Stage IV, eGFR <25 or Hemodialysis)
- Cognitive impairment
- Unable to self-manage (take medication, bathe, use the toilet, etc.)
- Currently living in a nursing home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEXT4HF 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 of symptoms, and heart failure knowledge.
- Primary Outcome Measures
Name Time Method Change in Self-care Symptom Perception 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 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 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 Outcome Measures
Name Time Method Heart Failure knowledge 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.
Change in Self-care confidence (self-efficacy) 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.
Health Beliefs about Dietary Compliance 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.
Health Related Quality of Life Baseline, 4 weeks, 12 weeks Assessed with Minnesota Living with Heart Failure Questionnaire; 21 questions, 5-point Likert scale
Health Beliefs about Self-Monitoring Compliance 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.
Health Beliefs about Medication Compliance 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.
Medication and Refill adherence Baseline, 4 weeks, 12 weeks Assessed with Adherence to Refilling Medication Scale (ARMS); 12 Items, 4-point Likert scale, lower scores indicate better adherence
Heart Healthy Diet Adherence 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
Trial Locations
- Locations (1)
University of Illinois, Chicago
🇺🇸Chicago, Illinois, United States