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NCT Number: NCT07485491

Enhancing Cardiac Rehabilitation Attendance After Secondary Myocardial Infarction Through Clinician Messaging and Motivational Calls

The goal of this clinical trial is to determine if a behavioral intervention can increase attendance at cardiac rehabilitation (CR) after secondary/type 2 myocardial infarction in adult patients. The main question it aims to answer is:

* Does the ATTEND-CR intervention increase attendance at ≥1 CR exercise session within 140 days of randomization? * Does the intervention increase completion of ≥12 CR exercise sessions within 140 days of randomization?

Researchers will compare participants receiving the ATTEND-CR intervention (clinician notifications and a motivational interviewing participant phone call) to usual care to see if attendance and completion of CR improve.

Participants:

* Clinicians will receive informational messaging regarding CR and the referral process * Participate in a motivational interviewing phone call (intervention group only) * Have follow-up assessments via telephone and electronic health record (EHR) review to track CR attendance, clinical events, and health outcomes

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Key information

Conditions

Type 2 Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The ATTEND-CR trial ("Activating Teams and Patients to Enhance Attendance at Cardiac Rehabilitation After Secondary Myocardial Infarction") is a single-center pilot randomized clinical trial designed to evaluate strategies to increase participation in cardiac rehabilitation (CR) among patients hospitalized with secondary/type 2 (demand/supply mismatch) myocardial infarction (MI). Although CR has been demonstrated to improve functional capacity, quality of life, and cardiovascular outcomes after acute MI, participation rates remain low, particularly in patients with secondary/type 2 MI. This study tests whether a low-risk, behavioral intervention can improve attendance in CR programs.

Participants are randomized to either the ATTEND-CR intervention or usual care. The intervention consists of informational messaging to clinicians regarding CR and the referral process, combined with a follow-up phone call to the patient applying principles of motivational interviewing to support their attendance at CR. Usual care participants receive standard post-MI management without study-driven notifications or motivational support.

Participants are followed for 140 days post-randomization. Study procedures include remote follow-up calls and review of electronic health records to capture participation in CR, clinical events, medication use, and patient-reported health status. The study team monitors safety throughout the trial, focusing on adverse events occurring during or shortly after CR sessions and any serious adverse events that arise during the follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Inpatient at MGH with an index secondary (type 2) MI
  • Primary care provider (PCP) within the Mass General Brigham (MGB) network with at least one visit in the past 2 years
  • Anticipated ability to ambulate independently without walking aids or supplemental ambulatory oxygen at discharge
  • Ability to provide informed consent

Exclusion criteria

  • Known severe untreated valvular heart disease or severe prosthetic valve dysfunction
  • Known hypertrophic obstructive cardiomyopathy
  • End-stage heart failure (VAD, transplant patient, or undergoing evaluation for VAD or transplant)
  • Hemodynamic instability at the time of pre-screening
  • Terminal illness with life expectancy < 1 year
  • Severe anemia (hemoglobin < 8 g/dL) at the time of pre-screening
  • Active, unstable cancer (excluding non-metastatic skin cancer) or currently receiving intensive cancer therapy
  • Advanced kidney disease requiring renal replacement therapy
  • Receiving palliative or comfort care only
  • Recurrent falls (≥2) or falls with injury in the past year
  • Physical or cognitive impairment likely to prevent safe participation in exercise over the next 5 months (e.g., significant stroke deficits, dementia)
  • High-risk for non-adherence to study requirements
  • Incarcerated individuals
  • Currently pregnant or within 3 months postpartum
  • Previously referred to or participated in CR within the past year
  • Alternative MI subtype (spontaneous [type 1 MI] or procedural MI [type 4 or 5 MI]) in the past 6 months
  • Suspected or confirmed coronary mechanism of index MI (vasospasm, embolism, or spontaneous coronary artery dissection)
  • Anticipated discharge or discharged before enrollment measures can be completed
  • Anticipated discharge to a facility where independent participation in CR is not feasible
  • Previously enrolled in or declined participation in this study

Treatment and study plan

Clinician-level intervention

Behavioral

The inpatient clinical team receives an EPIC in-basket and email detailing the patient's study participation, benefits of cardiac rehabilitation, and guidance on how to place a cardiac referral if appropriate.

If a cardiac rehabilitation referral is not placed within 3 days post-discharge, a follow-up message is sent to one of the patient's outpatient clinician within 4-28 days post-discharge and within 140 days of randomization.

Patient-level intervention

Behavioral

Participants receive a phone call applying motivational interviewing principles if a cardiac rehabilitation referral has been placed by their clinical team within 56 days post-discharge and within 140 days of randomization.

The phone call aims to discuss cardiac rehabilitation, barriers to participation, and support engagement in cardiac rehabilitation.

Primary outcomes

  1. Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session

    Time frame: Within 140 days (inclusive) post-randomization

    Attendance at one or more cardiac rehabilitation exercise session

Secondary outcomes

  1. Number of Participants With a Cardiac Rehabilitation Referral

    Time frame: Within 140 days (inclusive) post-randomization

    Referral to a cardiac rehabilitation program

  2. Number of Participants who Completed Cardiac Rehabilitation

    Time frame: Within 140 days (inclusive) post-randomization

    Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions

  3. Feasibility indicators

    Time frame: Recruitment Time Frame: Through completion of enrollment, an average of 18 months. Retention Time Frame: Through completion of participant follow-up, an average of 20 weeks.

    • Recruitment: Proportion of eligible patients randomized; threshold ≥40%.
    • Retention: Proportion completing interim or final follow-up; threshold ≥70%.

Other outcomes

  1. All-cause mortality

    Time frame: Within 140 days (inclusive) post-randomization

    All-cause mortality

  2. All-cause hospitalization

    Time frame: Within 140 days (inclusive) post randomization

    All-cause hospitalization

  3. Major adverse cardiovascular event

    Time frame: Within 140 days (inclusive) post randomization

    Composite of all-cause mortality, recurrent MI, unstable angina, stroke, TIA, or heart failure hospitalization

  4. Change in EuroQol 5-Dimension 5-Level questionnaire Visual Analogue Scale

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Self-rated health using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health

  5. Change in Seattle Angina Questionnaire - 7

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Angina-related health status measured using the Seattle Angina Questionnaire-7 (SAQ-7), a validated 7-item instrument assessing three domains: physical limitation, angina frequency, and quality of life. Scores are transformed to a 0-100 scale, where higher scores indicate better health status (fewer angina symptoms and less functional limitation).

  6. Change in FRAIL Scale Score

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Frailty status measured using the FRAIL Scale, a 5-item questionnaire assessing Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight. Scores range from 0 to 5, with 0 indicating robust, 1-2 indicating prefrail, and 3-5 indicating frail. Higher scores indicate greater frailty (worse health status).

  7. Change in PROMIS Physical Function Score

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Physical function measured using the PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Short Form 10a (PROMIS PF 10a). Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10, based on the U.S. general population. Higher scores indicate better physical function.

  8. Change in PROMIS Fatigue Score

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Fatigue measured using the PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue Short Form 4a (PROMIS Fatigue 4a). Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10, based on the U.S. general population. Higher scores indicate greater fatigue (worse outcome).

  9. Change in PROMIS Depression Score

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Depression measured using the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (PROMIS Depression 4a). Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10, based on the U.S. general population. Higher scores indicate greater depressive symptoms (worse outcome).

  10. Change in Rose Dyspnea Scale

    Time frame: Measured at baseline and between 140 to 154 days post-randomization

    Dyspnea measured using the Rose Dyspnea Scale, a scale assessing shortness of breath. Scores range from 0 (no dyspnea) to 4 (dyspnea on minimal exertion or at rest). Higher scores indicate more severe dyspnea (worse outcome).

  11. Number of Participants Who Are Current Smokers

    Time frame: Assessed between 140 to 154 days post randomization

    Currently/actively smoking.

  12. Number of Participants Taking Aspirin

    Time frame: Assessed between 140 to 154 days post randomization

    Aspirin use assessed via self-report and/or medication records at follow-up

  13. Number of Participants Taking a Statin

    Time frame: Assessed between 140 to 154 days post randomization

    Statin use assessed via self-report and/or medication records at follow-up.

  14. Adverse Events of Special Interest

    Time frame: Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization.

    These include:

    • Major cardiovascular/cerebrovascular events (MI, unstable angina, stroke/TIA, death)
    • Clinically significant arrhythmia requiring medical treatment
    • Hemodynamic instability (exercise induced hypotension requiring medical treatment other than oral hydration, hypertensive emergency requiring medical treatment, syncope)
    • Acute decompensated heart failure
    • Exercise-related injuries or complications (falls resulting in injury requiring medical attention or treatment, non-fall exercise related injuries requiring medical attention or treatment, hypoglycemia requiring medical treatment, hypoxia (non-HF related) requiring medical treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Cian McCarthy, MB, BCh, BAO, SM

CONTACT

[email protected]

617-726-2000

Connor Suscha, BS

CONTACT

[email protected]

617-643-2130

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Activating Teams and Patients to Enhance Attendance at Cardiac Rehabilitation After Secondary Myocardial Infarction (ATTEND-CR) Trial

Acronym: ATTEND-CR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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