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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Self-Care Maintenance [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Change in Self-care Symptom Perception [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Change in Self-care self-management [Срок оценки: Baseline, 4 weeks, 12 weeks]

Вторичные конечные точки (8)

• Health Beliefs about Medication Compliance [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Health Beliefs about Dietary Compliance [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Health Beliefs about Self-Monitoring Compliance [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Heart Failure knowledge [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Change in Self-care confidence (self-efficacy) [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Medication and Refill adherence [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Heart Healthy Diet Adherence [Срок оценки: Baseline, 4 weeks, 12 weeks]
• Heart Failure Quality of Life [Срок оценки: Baseline, 4 weeks, 12 weeks]

Критерии участия

Критерии включения

• ≥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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Illinois, Chicago — Chicago

Идентификаторы

NCT: NCT06473532 · 2022-0704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗