Myocardial Infarction Clinical Trial
Official title:
Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation
Verified date | July 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 38 |
Est. completion date | May 3, 2018 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | John L. Locke Jr. Charitable Trust |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of cardiac rehab sessions attended | Documented attendance at cardiac rehab sessions | 6 months | |
Secondary | 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 | |
Secondary | Exercise capacity | 6-minute walk test (6MWT) | 6 months | |
Secondary | Tobacco use | Participant self-report of tobacco use in past 30 days | 6 months | |
Secondary | Diet | Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet. | 6 months | |
Secondary | Blood pressure | Blood pressure measured by study staff | 6 months | |
Secondary | Body Mass Index (BMI) | Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2) | 6 months | |
Secondary | Cholesterol (LDL) | Obtained from medical records | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Patient activation | Self-reported activation via the Patient Activation Measure 13 (PAM-13) | 6 months | |
Secondary | Patient satisfaction | Self-reported satisfaction with the intervention | 6 months | |
Secondary | Patient experience | Self-reported experience with the intervention | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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