通过临床医生信息传递和激励性电话增强二次心肌梗死后的心脏康复参与度 (ATTEND-CR)
激活团队与患者以加强二次心肌梗死后心脏康复出席率(ATTEND-CR)试验
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Cian McCarthy, MB, BCh, BAO, SM
- 电话号码:617-726-2000
- 邮箱:CMCCARTHY37@MGB.ORG
研究联系人备份
- 姓名:Connor Suscha, BS
- 电话号码:617-643-2130
- 邮箱:csuscha@mgh.harvard.edu
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital
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接触:
- Connor Suscha, BS
- 电话号码:617-643-2130
- 邮箱:csuscha@mgh.harvard.edu
-
接触:
- Cian McCarthy, MB, BCh, BAO
- 电话号码:617-726-2000
- 邮箱:CMCCARTHY37@MGB.ORG
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
|
无干预: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session
大体时间:Within 140 days (inclusive) post-randomization
|
Attendance at one or more cardiac rehabilitation exercise session |
Within 140 days (inclusive) post-randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With a Cardiac Rehabilitation Referral
大体时间: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
大体时间:Within 140 days (inclusive) post-randomization
|
Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions |
Within 140 days (inclusive) post-randomization
|
|
Feasibility indicators
大体时间: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.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
All-cause mortality
大体时间:Within 140 days (inclusive) post-randomization
|
All-cause mortality |
Within 140 days (inclusive) post-randomization
|
|
All-cause hospitalization
大体时间:Within 140 days (inclusive) post randomization
|
All-cause hospitalization |
Within 140 days (inclusive) post randomization
|
|
Major adverse cardiovascular event
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Assessed between 140 to 154 days post randomization
|
Currently/actively smoking. |
Assessed between 140 to 154 days post randomization
|
|
Number of Participants Taking Aspirin
大体时间: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
大体时间: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
大体时间:Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization.
|
These include:
|
Occurring during or within 1 hour of participation in an exercise cardiac rehabilitation session up to 140 days post randomization.
|
合作者和调查者
调查人员
- 首席研究员:Cian P McCarthy, MB, BCh, BAO, SM、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified data generated from this study will be submitted to a data repository in accordance with NIH data sharing guidelines.
IPD 共享时间框架
Anticipated to be available at the time of publication of the study results.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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