Myocardial InfarctionNCT03346278
Text Message Intervention to Improve Cardiac Rehab Participation
A study testing Text Messaging Intervention in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery
- What is being tested?
- Text Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 3 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement, Heart Transplant, Left Ventricular Assist Device
- Being tested
- Text Messaging Intervention
- Keywords
- Cardiac Rehabilitation, Text Messaging
- Medical subject headings
- Myocardial Infarction, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Text Message Intervention | No intervention | Participants will receive usual care of information on CR and clinical referral to CR. |
| Text Message Intervention | Experimental | Participants randomized to the intervention will receive usual care plus a text messaging intervention. Receives: Behavioral: Text Messaging Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (17)
Number of cardiac rehab sessions attended
Documented attendance at cardiac rehab sessions
Measured: 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.
Measured: 6 months
Exercise capacity
6-minute walk test (6MWT)
Measured: 6 months
Tobacco use
Participant self-report of tobacco use in past 30 days
Measured: 6 months
Diet
Self-reported diet via Rate Your Plate questionnaire. Score 23-69, with 69 representing best diet.
Measured: 6 months
Blood pressure
Blood pressure measured by study staff
Measured: 6 months
Body Mass Index (BMI)
Weight measured by study staff. BMI = weight (kg) / height in meters squared (m2)
Measured: 6 months
Cholesterol (LDL)
Obtained from medical records
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Patient activation
Self-reported activation via the Patient Activation Measure 13 (PAM-13)
Measured: 6 months
Patient satisfaction
Self-reported satisfaction with the intervention
Measured: 6 months
Patient experience
Self-reported experience with the intervention
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start7 Nov 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Why it stopped: Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- John L. Locke Jr. Charitable Trust
- Responsible party
- Principal investigator, Alexis Beatty, University of Washington
- Investigators
- Alexis Beatty, MD, MAS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346278
- Sponsor's protocol ID
- STUDY00003125
- Status last verified
- Jul 2018
- First submitted
- 8 Nov 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share via University of Washington research data repository after the conclusion of the study and publication of findings
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Improve Heart Healthy Behaviors and Cardiac Rehabilitation Participation
- ClinicalTrials.gov ID
- NCT03346278
- Acronym / sponsor ID
- STUDY00003125
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement, Heart Transplant, Left Ventricular Assist Device
- Keywords
- Cardiac Rehabilitation, Text Messaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- John L. Locke Jr. Charitable Trust
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Text Message Intervention | No intervention | –Participants will receive usual care of information on CR and clinical referral to CR. |
| Text Message Intervention | Experimental | Behavioral: Text Messaging InterventionParticipants randomized to the intervention will receive usual care plus a text messaging intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging InterventionAfter 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. | Behavioural | Text Message Intervention |
Primary outcome
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.
17 secondary outcomes
Number of cardiac rehab sessions attended
Time frame: 6 months
Physical activity
Time frame: 6 months
Exercise capacity
Time frame: 6 months
Tobacco use
Time frame: 6 months
Diet
Time frame: 6 months
Blood pressure
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Cholesterol (LDL)
Time frame: 6 months
Disease-specific health status
Time frame: 6 months
Disease-specific health status
Time frame: 6 months
Depressive symptoms
Time frame: 6 months
Patient activation
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Patient experience
Time frame: 6 months
Hospitalizations
Time frame: 6 months
ER visits
Time frame: 6 months
Death
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: Undecided. Plan to share via University of Washington research data repository after the conclusion of the study and publication of findings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Beatty, MD, MAS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Intervention in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator leaving institution. 38 subjects were enrolled in Aim 1. Aim 2 was not initiated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at cardiac rehab (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.