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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL167659 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm (ATTEND-CR): | Experimental | 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. |
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| Usual Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | Within 140 days (inclusive) post-randomization |
| All-cause hospitalization | All-cause hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cian McCarthy, MB, BCh, BAO, SM | Contact | 617-726-2000 | CMCCARTHY37@MGB.ORG | |
| Connor Suscha, BS | Contact | 617-643-2130 | csuscha@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cian P McCarthy, MB, BCh, BAO, SM | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
De-identified data generated from this study will be submitted to a data repository in accordance with NIH data sharing guidelines.
Anticipated to be available at the time of publication of the study results.
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| 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. |
|
Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions
| Within 140 days (inclusive) post-randomization |
| Feasibility indicators |
| 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. |
| 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:
| Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization. |