Peer Mentored Approaches For Men And Women With Coronary Artery Disease ("4Steps")
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

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.
    

Intervention name(s): Peer Mentor; Transcendental Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A volunteer with a similar disease as the subject; A meditation technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention