이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

임상의 메시징과 동기부여 통화를 통한 이차 심근경색 이후 심장재활 참석률 향상 (ATTEND-CR)

2026년 9월 20일 업데이트: McCarthy, Cian, Massachusetts General Hospital

이차 심근 경색 후 심장 재활 참석률 향상을 위한 팀 및 환자 활성화(ATTEND-CR) 임상시험

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

연구 개요

상태

모병

정황

제2형 심근경색

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Cian McCarthy, MB, BCh, BAO, SM
전화번호: 617-726-2000
이메일: CMCCARTHY37@MGB.ORG

연구 연락처 백업

이름: Connor Suscha, BS
전화번호: 617-643-2130
이메일: csuscha@mgh.harvard.edu

연구 장소

미국
- Massachusetts
  - Boston, Massachusetts, 미국, 02114
    - 모병
    - Massachusetts General Hospital
    - 연락하다:
      
      Connor Suscha, BS
      
      전화번호: 617-643-2130
      
      이메일: csuscha@mgh.harvard.edu
    - 연락하다:
      
      Cian McCarthy, MB, BCh, BAO
      
      전화번호: 617-726-2000
      
      이메일: CMCCARTHY37@MGB.ORG

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: 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.	행동: 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. 행동: 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.
간섭 없음: 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.

참가자 그룹 / 팔

개입 / 치료

실험적: 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.

행동: 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.

행동: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session 기간: Within 140 days (inclusive) post-randomization	Attendance at one or more cardiac rehabilitation exercise session	Within 140 days (inclusive) post-randomization

2차 결과 측정

결과 측정	측정값 설명	기간
Number of Participants With a Cardiac Rehabilitation Referral 기간: 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 기간: Within 140 days (inclusive) post-randomization	Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions	Within 140 days (inclusive) post-randomization
Feasibility indicators 기간: 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.	Recruitment: Proportion of eligible patients randomized; threshold ≥40%. 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.

기타 결과 측정

결과 측정	측정값 설명	기간
All-cause mortality 기간: Within 140 days (inclusive) post-randomization	All-cause mortality	Within 140 days (inclusive) post-randomization
All-cause hospitalization 기간: Within 140 days (inclusive) post randomization	All-cause hospitalization	Within 140 days (inclusive) post randomization
Major adverse cardiovascular event 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: Assessed between 140 to 154 days post randomization	Currently/actively smoking.	Assessed between 140 to 154 days post randomization
Number of Participants Taking Aspirin 기간: 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 기간: 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 기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Massachusetts General Hospital

협력자

National Heart, Lung, and Blood Institute (NHLBI)

수사관

수석 연구원: Cian P McCarthy, MB, BCh, BAO, SM, Massachusetts General Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2028년 4월 1일

연구 완료 (추정된)

2028년 4월 1일

연구 등록 날짜

최초 제출

2026년 3월 12일

QC 기준을 충족하는 최초 제출

2026년 3월 16일

처음 게시됨 (실제)

2026년 3월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 20일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

2026P000632
5K23HL167659 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 지원 정보 유형

연구_프로토콜
ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

임상의 메시징과 동기부여 통화를 통한 이차 심근경색 이후 심장재활 참석률 향상 (ATTEND-CR)

이차 심근 경색 후 심장 재활 참석률 향상을 위한 팀 및 환자 활성화(ATTEND-CR) 임상시험

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

연구 연락처 백업

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (추정된)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

IPD 공유 기간

IPD 공유 지원 정보 유형

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구