Clinical trial NCT06473532: TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
Official title: TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
mHealth
Text Messaging
Mobile Phone
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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:

* 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

Primary outcomes:
measure: Change in Self-Care Maintenance
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in Self-care Symptom Perception
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in Self-care self-management
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Health Beliefs about Medication Compliance
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Health Beliefs about Dietary Compliance
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Health Beliefs about Self-Monitoring Compliance
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Heart Failure knowledge
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in Self-care confidence (self-efficacy)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Medication and Refill adherence
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Heart Healthy Diet Adherence
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Health Related Quality of Life
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Jonathan W Leigh, MPH, MSHI
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois Chicago
name: Spyros Kitsiou, PhD
role: STUDY_CHAIR
References: