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Amélioration de la participation à la réadaptation cardiaque après un infarctus du myocarde secondaire par le biais de messages cliniciens et d'appels motivationnels (ATTEND-CR)

20 septembre 2026 mis à jour par: McCarthy, Cian, Massachusetts General Hospital

Essai d'Activation des Équipes et des Patients pour Améliorer la Participation à la Réadaptation Cardiaque Après un Infarctus du Myocarde Secondaire (ATTEND-CR)

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Cian McCarthy, MB, BCh, BAO, SM
  • Numéro de téléphone: 617-726-2000
  • E-mail: CMCCARTHY37@MGB.ORG

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Recrutement
        • Massachusetts General Hospital
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.

Comportemental: 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session
Délai: Within 140 days (inclusive) post-randomization

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With a Cardiac Rehabilitation Referral
Délai: 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
Délai: Within 140 days (inclusive) post-randomization

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
All-cause mortality
Délai: Within 140 days (inclusive) post-randomization

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

12 mars 2026

Première soumission répondant aux critères de contrôle qualité

16 mars 2026

Première publication (Réel)

20 mars 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2026P000632
  • 5K23HL167659 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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