Clinical trial NCT03346278: Text Message Intervention to Improve Cardiac Rehab Participation
Official title: Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Percutaneous Coronary Intervention
Coronary Artery Bypass Surgery
Heart Valve Repair or Replacement
Heart Transplant
Left Ventricular Assist Device
Chronic Stable Angina
Chronic Stable Heart Failure
Keywords: Cardiac Rehabilitation
Text Messaging
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: John L. Locke Jr. Charitable Trust
First posted: 2017-11-17
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance at cardiac rehab
timeFrame: 6 months
Secondary outcomes:
measure: Number of cardiac rehab sessions attended
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Exercise capacity
timeFrame: 6 months
measure: Tobacco use
timeFrame: 6 months
measure: Diet
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: Cholesterol (LDL)
timeFrame: 6 months
measure: Disease-specific health status
timeFrame: 6 months
measure: Disease-specific health status
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Patient activation
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Patient experience
timeFrame: 6 months
measure: Hospitalizations
timeFrame: 6 months
measure: ER visits
timeFrame: 6 months
measure: Death
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Alexis Beatty, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: