Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Number of participants who are re-hospitalized during the trial
研究概览
简要总结
The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.
详细描述
To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and ~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Own or have reliable access to a smartphone or desktop computer with internet access
- •Have an email address
- •Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.
- •Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)
排除标准
- •Patients referred to cardiac rehab with ventricular assist devices.
研究组 & 干预措施
Conventional Center-Based Cardiac Rehab (CON)
Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
干预措施: Center-Based Cardiac Rehab (Other)
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
干预措施: Center-Based Cardiac Rehab (Other)
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
干预措施: mHealth (Other)
Home-Based Cardiac Rehab + mHealth (HOM+)
Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.
干预措施: mHealth (Other)
Home-Based Cardiac Rehab + mHealth (HOM+)
Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.
干预措施: Home-Based Cardiac Rehab (Other)
结局指标
主要结局
Number of participants who are re-hospitalized during the trial
时间窗: 1 Year
We will look at the number of patients who are hospitalized for any reason during the follow-up period
Functional Capacity
时间窗: 3 Months
VO2 peak
Change in Metabolic Equivalents of Task (METS)
时间窗: Baseline; 3 Months
The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure.
Number of Participants Who Were Re-hospitalized During the Trial
时间窗: 1 Year
The number of participants who were re-hospitalized during the trial.
Adherence to the Intervention
时间窗: Baseline to 3 Months
The percentage of completed visits per participant that were attended from the start of the intervention (baseline) to the end of the intervention (3 months) relative to the number of prescribed visits per participant.
次要结局
- Fasting Blood Glucose(3 Months)
- Fasting Hemoglobin(3 Months)
- Fasting Hemoglobin A1C(3 Months)
- Fasting Basic Lipid Panel(3 Months)
- Self-Reported Quality of Life(3 Months)
- 6 Minute Walk Test(3 Months)
- Self-Reported Physical Activity(3 Months)
- Self-Reported Dietary Patterns(3 Months)
- Change in Body Weight(3 Months)
- Change in Body Mass Index(Baseline; 3 Months)
- Change in Self-Reported Quality of Life(Baseline; 3 Months)
研究者
Thomas P. Olson, M.S., Ph.D.
Associate Professor of Medicine
Mayo Clinic