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Zwiększanie frekwencji w rehabilitacji kardiologicznej po wtórnym zawale mięśnia sercowego poprzez wiadomości od klinicystów i motywujące rozmowy telefoniczne (ATTEND-CR)

20 września 2026 zaktualizowane przez: McCarthy, Cian, Massachusetts General Hospital

Badanie Aktywacji Zespołów i Pacjentów w celu Zwiększenia Frekwencji w Rehabilitacji Kardiologicznej po Wtórnym Zawale Serca (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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

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

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Rekrutacyjny
        • Massachusetts General Hospital
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session
Ramy czasowe: Within 140 days (inclusive) post-randomization

Attendance at one or more cardiac rehabilitation exercise session

Within 140 days (inclusive) post-randomization

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With a Cardiac Rehabilitation Referral
Ramy czasowe: 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
Ramy czasowe: Within 140 days (inclusive) post-randomization

Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions

Within 140 days (inclusive) post-randomization
Feasibility indicators
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
All-cause mortality
Ramy czasowe: Within 140 days (inclusive) post-randomization

All-cause mortality

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

All-cause hospitalization

Within 140 days (inclusive) post randomization
Major adverse cardiovascular event
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Assessed between 140 to 154 days post randomization

Currently/actively smoking.

Assessed between 140 to 154 days post randomization
Number of Participants Taking Aspirin
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2028

Ukończenie studiów (Szacowany)

1 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

12 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 marca 2026

Pierwszy wysłany (Rzeczywisty)

20 marca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2026P000632
  • 5K23HL167659 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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