Zwiększanie frekwencji w rehabilitacji kardiologicznej po wtórnym zawale mięśnia sercowego poprzez wiadomości od klinicystów i motywujące rozmowy telefoniczne (ATTEND-CR)
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
Status
Warunki
Warunki
Interwencja / Leczenie
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
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
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
- Nazwa: Connor Suscha, BS
- Numer telefonu: 617-643-2130
- E-mail: csuscha@mgh.harvard.edu
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Rekrutacyjny
- Massachusetts General Hospital
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Kontakt:
- Connor Suscha, BS
- Numer telefonu: 617-643-2130
- E-mail: csuscha@mgh.harvard.edu
-
Kontakt:
- Cian McCarthy, MB, BCh, BAO
- Numer telefonu: 617-726-2000
- E-mail: CMCCARTHY37@MGB.ORG
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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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
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
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.
|
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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
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
|
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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:
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Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization.
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Cian P McCarthy, MB, BCh, BAO, SM, Massachusetts General Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 2026P000632
- 5K23HL167659 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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
Bada produkt urządzenia regulowany przez amerykańską FDA
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