TEXT4HF: A Randomized Controlled Trial of a Tailored Text Messaging Intervention to Improve Self-Care in Older Adult Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Self-care Symptom Perception
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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)
排除标准
- •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
结局指标
主要结局
Change in Self-care Symptom Perception
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Heart Healthy Diet Adherence(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Medication Compliance(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Dietary Compliance(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Self-Monitoring Compliance(Baseline, 4 weeks, 12 weeks)
- Heart Failure knowledge(Baseline, 4 weeks, 12 weeks)
- Change in Self-care confidence (self-efficacy)(Baseline, 4 weeks, 12 weeks)
- Medication and Refill adherence(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Medication Compliance(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Dietary Compliance(Baseline, 4 weeks, 12 weeks)
- Health Beliefs about Self-Monitoring Compliance(Baseline, 4 weeks, 12 weeks)
- Heart Failure knowledge(Baseline, 4 weeks, 12 weeks)
- Change in Self-care confidence (self-efficacy)(Baseline, 4 weeks, 12 weeks)
- Medication and Refill adherence(Baseline, 4 weeks, 12 weeks)
- Heart Healthy Diet Adherence(Baseline, 4 weeks, 12 weeks)
- Heart Failure Quality of Life(Baseline, 4 weeks, 12 weeks)
研究者
Jonathan W. Leigh
PhD Candidate
University of Illinois at Chicago