Text Message Intervention to Improve Cardiac Rehab Participation

Myocardial Infarction Clinical Trial

Official title:

Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03346278
• Other study ID #: STUDY00003125
• Status: Terminated
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: July 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Text Messaging Intervention
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.

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	John L. Locke Jr. Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

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