Text Message Intervention to Improve Cardiac Rehab Participation
- Conditions
- Myocardial InfarctionHeart TransplantChronic Stable Heart FailureCoronary Artery Bypass SurgeryHeart Valve Repair or ReplacementPercutaneous Coronary InterventionLeft Ventricular Assist DeviceChronic Stable Angina
- Interventions
- Behavioral: Text Messaging Intervention
- Registration Number
- NCT03346278
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- 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
- Unable to communicate in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Text Message Intervention Text Messaging Intervention Participants randomized to the intervention will receive usual care plus a text messaging intervention.
- Primary Outcome Measures
Name Time Method Attendance at cardiac rehab 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.
- Secondary Outcome Measures
Name Time Method Number of cardiac rehab sessions attended 6 months Documented attendance at cardiac rehab sessions
Patient activation 6 months Self-reported activation via the Patient Activation Measure 13 (PAM-13)
Patient satisfaction 6 months Self-reported satisfaction with the intervention
Tobacco use 6 months Participant self-report of tobacco use in past 30 days
Cholesterol (LDL) 6 months Obtained from medical records
Physical activity 6 months Self-reported via International Physical Activity Questionnaire (IPAQ) - Total physical activity in continuous MET-min/week. Total physical activity is the sum of walking, moderate, and vigorous physical activity. Walking MET-minutes/week = 3.3 \* walking minutes \* walking days. Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days. Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days.
Exercise capacity 6 months 6-minute walk test (6MWT)
Body Mass Index (BMI) 6 months Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2)
Death 6 months Confirm participant-reported events from medical records. We will report a composite of number of participants with Hospitalizations, ER visits, or Death, as well as number of participants with each individual outcome.
Depressive symptoms 6 months Self-reported depressive symptoms via Patient Health Questionnaire-9 (PHQ-9). Scored 0-27 with 0 representing no depressive symptoms and 27 representing severe depressive symptoms.
Diet 6 months Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet.
Blood pressure 6 months Blood pressure measured by study staff
Disease-specific health status 6 months Self-reported health status via validated Kansas City Cardiomyopathy Questionnaire (KCCQ) - Short Form for participants with heart failure or valvular heart disease. The questionnaire is scored from 0-100 with 100 being the highest reportable health status. KCCQ domains will include: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitation.
Patient experience 6 months Self-reported experience with the intervention
ER visits 6 months Confirm participant-reported events from medical records. We will report a composite of number of participants with Hospitalizations, ER visits, or Death, as well as number of participants with each individual outcome.
Hospitalizations 6 months Confirm participant-reported events from medical records. We will report a composite of number of participants with Hospitalizations, ER visits, or Death, as well as number of participants with each individual outcome.
Trial Locations
- Locations (1)
University of Washington Medical Center
🇺🇸Seattle, Washington, United States