Text Message Intervention to Improve Cardiac Rehab Participation

Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Bypass Surgery; Chronic Stable Angina; Left Ventricular Assist Device; Heart Transplant; Chronic Stable Heart Failure; Heart Valve Repair or Replacement
• Intervention / Treatment: Behavioral: Text Messaging Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Text Message Intervention; Participants will receive usual care of information on CR and clinical referral to CR.
Experimental: Text Message Intervention; Participants randomized to the intervention will receive usual care plus a text messaging 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: John L. Locke Jr. Charitable Trust
• Investigators: Principal Investigator: Alexis Beatty, MD, MAS, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): May 3, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation; Text Messaging
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Angina, Stable
• Other Study ID Numbers: STUDY00003125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan to share via University of Washington research data repository after the conclusion of the study and publication of findings

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No