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临床试验/NCT03346278
NCT03346278终止不适用

Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation

University of Washington2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
2
主要终点
Attendance at cardiac rehab

研究概览

简要总结

Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low. This study will examine if a mobile phone intervention that uses a text messaging program can successfully promote participation in cardiac rehabilitation.

详细描述

Mobile phone interventions, such as text messaging programs, have been shown to promote healthy behaviors in patients with coronary heart disease, but it is unknown whether text messaging can successfully promote participation in cardiac rehabilitation.

This study will have the following aims:

Aim 1: Adapt a theory- and evidence-based text messaging intervention to promote participation in cardiac rehabilitation.

Aim 2: Determine whether text messaging improves participation in cardiac rehabilitation among eligible patients.

This study will have two parts. In part 1, the investigators will enroll patients with heart disease to rate the acceptability of text messages. In part 2, the investigators will enroll patients to participate in a randomized controlled trial. Participants will be randomized to receive text messages or no text messages for 6 months. Those who have been assigned to receive the text messaging intervention will be sent several text messages per week throughout the study period. The content of these text messages is designed promote healthy behaviors and participation in cardiac rehabilitation. Those who have not been assigned to receive the text messaging intervention will receive usual care. Outcome measures will be assessed at a baseline visit and at a 6-month follow-up visit at the end of the intervention. Additionally, some participants in the text messaging intervention group will be interviewed about their overall satisfaction and engagement with the text messages upon completion of the study.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Part 1: Diagnosis eligible for cardiac rehabilitation within 90 days (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device, chronic stable angina, chronic stable heart failure)
  • Part 2: Hospitalized for diagnosis eligible for cardiac rehabilitation (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device)
  • Eligible for cardiac rehabilitation
  • Owns a smartphone capable of receiving and sending SMS text messages

排除标准

  • Unable to communicate in English

研究组 & 干预措施

No Text Message Intervention

No Intervention

Participants will receive usual care of information on CR and clinical referral to CR.

Text Message Intervention

Experimental

Participants randomized to the intervention will receive usual care plus a text messaging intervention.

干预措施: Text Messaging Intervention (Behavioral)

结局指标

主要结局

Attendance at cardiac rehab

时间窗: 6 months

Documented attendance at one or more cardiac rehab sessions. Primary analysis will compare the proportion attending cardiac rehab in the text message intervention and no text message intervention arms.

次要结局

  • Patient activation(6 months)
  • Patient satisfaction(6 months)
  • Tobacco use(6 months)
  • Cholesterol (LDL)(6 months)
  • Number of cardiac rehab sessions attended(6 months)
  • Physical activity(6 months)
  • Body Mass Index (BMI)(6 months)
  • Exercise capacity(6 months)
  • Death(6 months)
  • Diet(6 months)
  • Blood pressure(6 months)
  • Depressive symptoms(6 months)
  • Patient experience(6 months)
  • ER visits(6 months)
  • Hospitalizations(6 months)
  • Disease-specific health status(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexis Beatty

Assistant Professor, Department of Medicine

University of Washington

研究点 (2)

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