Text Message Intervention to Improve Cardiac Rehab Participation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation

Conditions
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Heart Transplant, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement, Left Ventricular Assist Device, Chronic Stable Angina, Chronic Stable Heart Failure

Intervention / Treatment
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* Behavioral: Text Messaging Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unable to communicate in English

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Text Message Intervention<br>Participants will receive usual care of information on CR and clinical referral to CR. | |
| Experimental: Text Message Intervention<br>Participants randomized to the intervention will receive usual care plus a text messaging intervention. | Behavioral: Text Messaging Intervention<br>* After completing baseline procedures, study staff will activate the intervention in the participant's profile on the text messaging platform if the participant was randomized to the intervention. The text messaging platform will deliver messages by an automated algorithm. Participants will receive 4 messages per week for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance at cardiac rehab | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiac rehab sessions attended | Documented attendance at cardiac rehab sessions | 6 months | 
| Physical activity | 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. | 6 months | 
| Exercise capacity | 6-minute walk test (6MWT) | 6 months | 
| Tobacco use | Participant self-report of tobacco use in past 30 days | 6 months | 
| Diet | Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet. | 6 months | 
| Blood pressure | Blood pressure measured by study staff | 6 months | 
| Body Mass Index (BMI) | Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2) | 6 months | 
| Cholesterol (LDL) | Obtained from medical records | 6 months | 
| Disease-specific health status | Self-reported health status via validated Seattle Angina Questionnaire (SAQ) - Short Form for participants with ischemic heart disease. The questionnaire is scored from 0-100 with 100 being the highest reportable health status. SAQ domains will include: Physical Limitation, Angina Frequency, and Quality of Life. | 6 months | 
| Disease-specific health status | 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. | 6 months | 
| Depressive symptoms | 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. | 6 months | 
| Patient activation | Self-reported activation via the Patient Activation Measure 13 (PAM-13) | 6 months | 
| Patient satisfaction | Self-reported satisfaction with the intervention | 6 months | 
| Patient experience | Self-reported experience with the intervention | 6 months | 
| Hospitalizations | 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. | 6 months | 
| ER visits | 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. | 6 months | 
| Death | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Rehabilitation, Text Messaging