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
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 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
研究组 & 干预措施
TEXT4HF
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, and heart failure knowledge.
干预措施: TEXT4HF (Behavioral)
Control Group
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.
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)
- Heart Failure Quality of Life(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)
研究者
Jonathan W. Leigh
PhD Candidate
University of Illinois at Chicago