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Verbeteren van deelname aan hartrevalidatie na een secundair myocardinfarct via berichten van clinici en motiverende telefoongesprekken (ATTEND-CR)

20 september 2026 bijgewerkt door: McCarthy, Cian, Massachusetts General Hospital

Activering van Teams en Patiënten om Deelname aan Hartrevalidatie te Verbeteren na een Secundair Myocardinfarct (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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Werving
        • Massachusetts General Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.

Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session
Tijdsspanne: Within 140 days (inclusive) post-randomization

Attendance at one or more cardiac rehabilitation exercise session
Within 140 days (inclusive) post-randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With a Cardiac Rehabilitation Referral
Tijdsspanne: 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
Tijdsspanne: Within 140 days (inclusive) post-randomization

Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions
Within 140 days (inclusive) post-randomization
Feasibility indicators
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
All-cause mortality
Tijdsspanne: Within 140 days (inclusive) post-randomization

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

All-cause hospitalization
Within 140 days (inclusive) post randomization
Major adverse cardiovascular event
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Assessed between 140 to 154 days post randomization

Currently/actively smoking.
Assessed between 140 to 154 days post randomization
Number of Participants Taking Aspirin
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Massachusetts General Hospital

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

1 april 2028

Studieregistratiedata

Eerst ingediend

12 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 maart 2026

Eerst geplaatst (Werkelijk)

20 maart 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 september 2026

Laatste update ingediend die voldeed aan QC-criteria

20 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2026P000632
  • 5K23HL167659 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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