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Forbedring af deltagelse i hjerterehabilitering efter sekundært myokardieinfarkt gennem klinikerbeskeder og motiverende opkald (ATTEND-CR)

20. september 2026 opdateret af: McCarthy, Cian, Massachusetts General Hospital

Aktivering af Teams og Patienter for at Forbedre Deltagelse i Hjerterehabilitering Efter Sekundær Myokardieinfarkt (ATTEND-CR) Studie

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Cian McCarthy, MB, BCh, BAO, SM
  • Telefonnummer: 617-726-2000
  • E-mail: CMCCARTHY37@MGB.ORG

Undersøgelse Kontakt Backup

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • Inpatient at MGH with an index likely or confirmed secondary 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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.

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.

Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session
Tidsramme: Within 140 days (inclusive) post-randomization

Attendance at one or more cardiac rehabilitation exercise session

Within 140 days (inclusive) post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With a Cardiac Rehabilitation Referral
Tidsramme: Within 140 days (inclusive) post-randomization

Referral to a cardiac rehabilitation program

Within 140 days (inclusive) post-randomization
Number of Participants who Completed Cardiac Rehabilitation
Tidsramme: Within 140 days (inclusive) post-randomization

Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions

Within 140 days (inclusive) post-randomization
Feasibility indicators
Tidsramme: 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.
  1. Recruitment: Proportion of eligible patients randomized; threshold ≥40%.
  2. 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: Within 140 days (inclusive) post-randomization

All-cause mortality

Within 140 days (inclusive) post-randomization
All-cause hospitalization
Tidsramme: Within 140 days (inclusive) post randomization

All-cause hospitalization

Within 140 days (inclusive) post randomization
Major adverse cardiovascular event
Tidsramme: Within 140 days (inclusive) post randomization

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
Tidsramme: 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

Measured at baseline and between 140 to 154 days post-randomization
Change in Seattle Angina Questionnaire - 7
Tidsramme: 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).

Measured at baseline and between 140 to 154 days post-randomization
Change in FRAIL Scale Score
Tidsramme: 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).

Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Physical Function Score
Tidsramme: 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.

Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Fatigue Score
Tidsramme: 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).

Measured at baseline and between 140 to 154 days post-randomization
Change in PROMIS Depression Score
Tidsramme: 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).

Measured at baseline and between 140 to 154 days post-randomization
Change in Rose Dyspnea Scale
Tidsramme: 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).

Measured at baseline and between 140 to 154 days post-randomization
Number of Participants Who Are Current Smokers
Tidsramme: Assessed between 140 to 154 days post randomization

Currently/actively smoking.

Assessed between 140 to 154 days post randomization
Number of Participants Taking Aspirin
Tidsramme: Assessed between 140 to 154 days post randomization

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
Tidsramme: Assessed between 140 to 154 days post randomization

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Cian P McCarthy, MB, BCh, BAO, SM, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

12. marts 2026

Først indsendt, der opfyldte QC-kriterier

16. marts 2026

Først opslået (Faktiske)

20. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026P000632
  • 5K23HL167659 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data generated from this study will be submitted to a data repository in accordance with NIH data sharing guidelines.

IPD-delingstidsramme

Anticipated to be available at the time of publication of the study results.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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