TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEXT4HF.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral 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.
Primary outcome measures
- Change in Self-Care Maintenance [Time frame: Baseline, 4 weeks, 12 weeks]
- Change in Self-care Symptom Perception [Time frame: Baseline, 4 weeks, 12 weeks]
- Change in Self-care self-management [Time frame: Baseline, 4 weeks, 12 weeks]
Secondary outcome measures (8)
- Health Beliefs about Medication Compliance [Time frame: Baseline, 4 weeks, 12 weeks]
- Health Beliefs about Dietary Compliance [Time frame: Baseline, 4 weeks, 12 weeks]
- Health Beliefs about Self-Monitoring Compliance [Time frame: Baseline, 4 weeks, 12 weeks]
- Heart Failure knowledge [Time frame: Baseline, 4 weeks, 12 weeks]
- Change in Self-care confidence (self-efficacy) [Time frame: Baseline, 4 weeks, 12 weeks]
- Medication and Refill adherence [Time frame: Baseline, 4 weeks, 12 weeks]
- Heart Healthy Diet Adherence [Time frame: Baseline, 4 weeks, 12 weeks]
- Heart Failure Quality of Life [Time frame: Baseline, 4 weeks, 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Illinois, Chicago — Chicago
Identifiers
NCT: NCT06473532 · 2022-0704