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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 logo

University of Illinois

Status

Enrolling

Conditions

Heart Failure

Treatments

Behavioral: TEXT4HF

Study type

Interventional

Funder types

Other

Identifiers

NCT06473532
2022-0704

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

TEXT4HF
Experimental group
Description:
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.
Treatment:
Behavioral: TEXT4HF
Control Group
No Intervention group
Description:
The control group will receive standard HF medical care, which includes nurse-led patient education about HF self-care before and/or after discharge as well as follow-up visits at the Outpatient Heart Failure Clinic at UIH post-hospital discharge and several times per year or more, depending on the severity of the patient's condition. Participants will also receive the AHA information packet for patients with HF.

Trial contacts and locations

1

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Central trial contact

Spyros Kitsiou, PhD; Jonathan W Leigh, MPH, MSHI

Data sourced from clinicaltrials.gov

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