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Text Message Intervention to Improve Cardiac Rehab Participation

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ClinicalTrials.gov Identifier: NCT03346278
Recruitment Status : Terminated (Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.)
First Posted : November 17, 2017
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
John L. Locke Jr. Charitable Trust
Information provided by (Responsible Party):
Alexis Beatty, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Text Messaging Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Attendance at cardiac rehab [ Time Frame: 6 months ]
    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 :
  1. Number of cardiac rehab sessions attended [ Time Frame: 6 months ]
    Documented attendance at cardiac rehab sessions

  2. Physical activity [ Time Frame: 6 months ]
    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.

  3. Exercise capacity [ Time Frame: 6 months ]
    6-minute walk test (6MWT)

  4. Tobacco use [ Time Frame: 6 months ]
    Participant self-report of tobacco use in past 30 days

  5. Diet [ Time Frame: 6 months ]
    Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet.

  6. Blood pressure [ Time Frame: 6 months ]
    Blood pressure measured by study staff

  7. Body Mass Index (BMI) [ Time Frame: 6 months ]
    Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2)

  8. Cholesterol (LDL) [ Time Frame: 6 months ]
    Obtained from medical records

  9. Disease-specific health status [ Time Frame: 6 months ]
    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.

  10. Disease-specific health status [ Time Frame: 6 months ]
    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.

  11. Depressive symptoms [ Time Frame: 6 months ]
    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.

  12. Patient activation [ Time Frame: 6 months ]
    Self-reported activation via the Patient Activation Measure 13 (PAM-13)

  13. Patient satisfaction [ Time Frame: 6 months ]
    Self-reported satisfaction with the intervention

  14. Patient experience [ Time Frame: 6 months ]
    Self-reported experience with the intervention

  15. Hospitalizations [ Time Frame: 6 months ]
    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.

  16. ER visits [ Time Frame: 6 months ]
    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.

  17. Death [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346278


Locations
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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
John L. Locke Jr. Charitable Trust
Investigators
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Principal Investigator: Alexis Beatty, MD, MAS University of Washington
More Information
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Responsible Party: Alexis Beatty, Assistant Professor, Department of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03346278    
Other Study ID Numbers: STUDY00003125
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share via University of Washington research data repository after the conclusion of the study and publication of findings

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexis Beatty, University of Washington:
Cardiac Rehabilitation
Text Messaging
Additional relevant MeSH terms:
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Myocardial Infarction
Angina, Stable
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations