NCT03020316

Peer Mentored Approaches For Men And Women With Coronary Artery Disease ("4Steps")

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. SOC may include routine outpatient physician assessment, preventive medications with appropriate titration, routine blood draws, advice on lifestyle change, referral to cardiac rehabilitation, use of commercially available medical apps. Investigation - use of peer mentor and use of transcendental meditation. 1. Peer mentor: These are volunteers with CAD, who will undergo training prior to be assigned a mentee. Content of the training will focus on a review of health counseling, basics of CAD pathophysiology and medications, information on situations where the mentor should advise the subject to contact her doctor, and confidentiality. Mentors are intended to provide psychosocial and limited educational support for subjects. 2. Transcendental meditation (TM). TM is a standardized meditation technique done 20 minutes twice each day while sitting with the eyes closed. Although data are heterogeneous, TM has been demonstrated to reduce blood pressure in several small studies.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
BEHAVIORAL	Peer Mentor	A volunteer with a similar disease as the subject
BEHAVIORAL	Transcendental Meditation	A meditation technique

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-10-06
• Completion: 2019-11-22
• First posted: 2017-01-13
• Last updated: 2019-11-26

Locations

1 site across 1 country: United States