Peer Mentored Approaches For Men And Women With Coronary Artery Disease ("4Steps")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Perceived Stress
研究概览
简要总结
This study will be a pilot prospective randomized study using a peer mentor with or without Transcendental Meditation as compared to usual care for men and women with a new diagnosis of coronary artery disease (CAD). The study is designed to explore between cohort comparisons of perceived stress and a number of additional outcomes. The results of this pilot study will be used in the design of larger future trials.
The target population is adult men and women with a new diagnosis of CAD made on the basis of a myocardial infarction, coronary revascularization procedure, acute coronary syndrome, or imaging test suggestive of CAD.
The overall hypothesis of this proposal is that the addition of a peer mentor and training in Transcendental Meditation to usual care will improve perceived stress and medication adherence for men and women with newly diagnosed CAD as compared with usual care.
详细描述
The overall hypothesis of this proposal is that the addition of a peer mentor and training in Transcendental Meditation to usual care will improve perceived stress and medication adherence for men and women with newly diagnosed CAD as compared with usual care.
Participants will be "randomized" into one of two study groups:
Arm 1 - Standard Of Care (SOC) Arm 3 - SOC, assignment of a peer mentor, and the opportunity to receive training in transcendental meditation
We are no longer enrolling in Arm 2 of the study (SOC and subjects addition of a peer mentor).
Subjects will be assessed at baseline, 1 month, 6 months, and 12 months with surveys and assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Participants:
- •Men and women aged 18-90
- •English speaking
- •Newly diagnosed with CAD (myocardial infarction [MI], percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG]), acute coronary syndrome, or any imaging test suggestive of CAD).
- •For Mentors:
- •(Male mentors will be paired with male participants, and female mentors will be paired with female participants.)
- •Men and women aged 18-90
- •English speaking
- •Established (greater than 1yr prior to study) diagnosis of CAD (myocardial infarction [MI], percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG] acute coronary syndrome, or imaging test suggestive of CAD).
排除标准
- •For Participants:
- •Previously diagnosed CAD (MI, PCI, CABG, acute coronary syndrome or imaging test suggestive of CAD)
- •Inability or unwillingness to provide written consent
- •Non-English speaking
- •Prior formal training and practice of TM
- •For Mentors:
- •Inability or unwillingness to provide written consent
- •Non-English speaking
研究组 & 干预措施
Usual Care
Subjects will be encouraged to follow-up with their primary physicians.
Subjects will be informed that they will be periodically contacted by telephone and/or email by the research team for future assessments.
Peer Mentor & Transcendental Meditation
Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.
In addition to the peer mentor, subjects will be instructed in transcendental meditation (TM) in the standard manner by a trained TM instructor.
干预措施: Peer Mentor (Behavioral)
Peer Mentor & Transcendental Meditation
Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.
In addition to the peer mentor, subjects will be instructed in transcendental meditation (TM) in the standard manner by a trained TM instructor.
干预措施: Transcendental Meditation (Behavioral)
Peer Mentor
We are no longer recruiting in this arm.
Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.
干预措施: Peer Mentor (Behavioral)
结局指标
主要结局
Perceived Stress
时间窗: 52 weeks
Cohen Perceived Stress Scale (PSS-10) Each item is rated on a 5-point scale ranging from never (0) to almost always (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. Total scale range: 0-40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress.
次要结局
- Heart rate(52 weeks)
- Waist circumference(52 weeks)
- Lipid panel results(52 weeks)
- Fasting plasma glucose(52 weeks)
- Hospital readmission(52 weeks)
- Changes in physical activity(52 weeks)
- Number and manner of contacts between participants and mentors(52 weeks)
- Participant feedback about mentorship and TM(52 weeks)
- Participant knowledge about CAD(52 weeks)
- Height(52 weeks)
- Weight(52 weeks)
- Blood pressure(52 weeks)
- Medication Adherence (ARMS-7)(52 weeks)
- Medication Adherence (VAS)(52 weeks)
- Depressive Symptoms(52 weeks)