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Text Message Intervention to Improve Cardiac Rehab Participation

Primary Purpose

Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Cardiac Rehabilitation, Text Messaging

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Text Message Intervention

Text Message Intervention

Arm Description

Participants will receive usual care of information on CR and clinical referral to CR.

Participants randomized to the intervention will receive usual care plus a text messaging intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of cardiac rehab sessions attended
Documented attendance at cardiac rehab sessions
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.
Exercise capacity
6-minute walk test (6MWT)
Tobacco use
Participant self-report of tobacco use in past 30 days
Diet
Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet.
Blood pressure
Blood pressure measured by study staff
Body Mass Index (BMI)
Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2)
Cholesterol (LDL)
Obtained from medical records
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.
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.
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.
Patient activation
Self-reported activation via the Patient Activation Measure 13 (PAM-13)
Patient satisfaction
Self-reported satisfaction with the intervention
Patient experience
Self-reported experience with the intervention
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.
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.
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.

Full Information

First Posted
November 8, 2017
Last Updated
July 10, 2018
Sponsor
University of Washington
Collaborators
John L. Locke Jr. Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03346278
Brief Title
Text Message Intervention to Improve Cardiac Rehab Participation
Official Title
Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
John L. Locke Jr. Charitable Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Text Message Intervention
Arm Type
No Intervention
Arm Description
Participants will receive usual care of information on CR and clinical referral to CR.
Arm Title
Text Message Intervention
Arm Type
Experimental
Arm Description
Participants randomized to the intervention will receive usual care plus a text messaging intervention.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance at cardiac rehab
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of cardiac rehab sessions attended
Description
Documented attendance at cardiac rehab sessions
Time Frame
6 months
Title
Physical activity
Description
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.
Time Frame
6 months
Title
Exercise capacity
Description
6-minute walk test (6MWT)
Time Frame
6 months
Title
Tobacco use
Description
Participant self-report of tobacco use in past 30 days
Time Frame
6 months
Title
Diet
Description
Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet.
Time Frame
6 months
Title
Blood pressure
Description
Blood pressure measured by study staff
Time Frame
6 months
Title
Body Mass Index (BMI)
Description
Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2)
Time Frame
6 months
Title
Cholesterol (LDL)
Description
Obtained from medical records
Time Frame
6 months
Title
Disease-specific health status
Description
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.
Time Frame
6 months
Title
Disease-specific health status
Description
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.
Time Frame
6 months
Title
Depressive symptoms
Description
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.
Time Frame
6 months
Title
Patient activation
Description
Self-reported activation via the Patient Activation Measure 13 (PAM-13)
Time Frame
6 months
Title
Patient satisfaction
Description
Self-reported satisfaction with the intervention
Time Frame
6 months
Title
Patient experience
Description
Self-reported experience with the intervention
Time Frame
6 months
Title
Hospitalizations
Description
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.
Time Frame
6 months
Title
ER visits
Description
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.
Time Frame
6 months
Title
Death
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Beatty, MD, MAS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan to share via University of Washington research data repository after the conclusion of the study and publication of findings

Learn more about this trial

Text Message Intervention to Improve Cardiac Rehab Participation

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