Enhancing Cardiac Rehabilitation Attendance After Secondary Myocardial Infarction Through Clinician Messaging and Motivational Calls (ATTEND-CR)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Myocardial Infarction
• Intervention / Treatment: Behavioral: Clinician-level intervention; Behavioral: Patient-level intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cian McCarthy, MB, BCh, BAO, SM; Phone Number: 617-726-2000; Email: CMCCARTHY37@MGB.ORG
• Study Contact Backup: Name: Connor Suscha, BS; Phone Number: 617-643-2130; Email: csuscha@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Connor Suscha, BS; Phone Number: 617-643-2130; Email: csuscha@mgh.harvard.edu
      • Contact: Cian McCarthy, MB, BCh, BAO; Phone Number: 617-726-2000; Email: CMCCARTHY37@MGB.ORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm (ATTEND-CR): Participants clinicians receive an informational message about cardiac rehabilitation and the cardiac rehabilitation referral process. Participants who are referred to cardiac rehabilitation receive a phone call post-discharge applying principles of motivational interviewing. The goal is to encourage cardiac rehabilitation attendance.	Behavioral: Clinician-level intervention; 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.; Behavioral: Patient-level intervention; 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.
No Intervention: Usual Care Arm; Participants receive standard post-MI care without clinician informative messaging or a motivational interviewing phone call from the study team. They may still be referred to and attend CR based on usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session	Attendance at one or more cardiac rehabilitation exercise session	Within 140 days (inclusive) post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Cardiac Rehabilitation Referral	Referral to a cardiac rehabilitation program	Within 140 days (inclusive) post-randomization
Number of Participants who Completed Cardiac Rehabilitation	Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions	Within 140 days (inclusive) post-randomization
Feasibility indicators	Recruitment: Proportion of eligible patients randomized; threshold ≥40%.; Retention: Proportion completing interim or final follow-up; threshold ≥70%.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	Within 140 days (inclusive) post-randomization
All-cause hospitalization	All-cause hospitalization	Within 140 days (inclusive) post randomization
Major adverse cardiovascular event	Composite of all-cause mortality, recurrent MI, unstable angina, stroke, TIA, or heart failure hospitalization	Within 140 days (inclusive) post randomization
Change in EuroQol 5-Dimension 5-Level questionnaire Visual Analogue Scale	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	Measured at baseline and between 140 to 154 days post-randomization
Change in Seattle Angina Questionnaire - 7	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).	Measured at baseline and between 140 to 154 days post-randomization
Change in FRAIL Scale Score	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).	Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Physical Function Score	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.	Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Fatigue Score	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).	Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Depression Score	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).	Measured at baseline and between 140 to 154 days post-randomization
Change in Rose Dyspnea Scale	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).	Measured at baseline and between 140 to 154 days post-randomization
Number of Participants Who Are Current Smokers	Currently/actively smoking.	Assessed between 140 to 154 days post randomization
Number of Participants Taking Aspirin	Aspirin use assessed via self-report and/or medication records at follow-up	Assessed between 140 to 154 days post randomization
Number of Participants Taking a Statin	Statin use assessed via self-report and/or medication records at follow-up.	Assessed between 140 to 154 days post randomization
Adverse Events of Special Interest	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.	Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Cian P McCarthy, MB, BCh, BAO, SM, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation; Type 2 myocardial infarction; Secondary myocardial infarction
• Other Study ID Numbers: 2026P000632; 5K23HL167659 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data generated from this study will be submitted to a data repository in accordance with NIH data sharing guidelines.
• IPD Sharing Time Frame: Anticipated to be available at the time of publication of the study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No