Clinical trial NCT03020316: Peer Mentored Approaches For Men And Women With Coronary Artery Disease ("4Steps")
Official title: Peer Mentored Approaches For Men And Women With Coronary Artery Disease ("4Steps")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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

Primary outcomes:
measure: Perceived Stress
timeFrame: 52 weeks
Secondary outcomes:
measure: Medication Adherence (ARMS-7)
timeFrame: 52 weeks
measure: Medication Adherence (VAS)
timeFrame: 52 weeks
measure: Depressive Symptoms
timeFrame: 52 weeks
measure: Height
timeFrame: 52 weeks
measure: Weight
timeFrame: 52 weeks
measure: Blood pressure
timeFrame: 52 weeks
measure: Heart rate
timeFrame: 52 weeks
measure: Waist circumference
timeFrame: 52 weeks
measure: Lipid panel results
timeFrame: 52 weeks
measure: Fasting plasma glucose
timeFrame: 52 weeks
measure: Hospital readmission
timeFrame: 52 weeks
measure: Changes in physical activity
timeFrame: 52 weeks
measure: Number and manner of contacts between participants and mentors
timeFrame: 52 weeks
measure: Participant feedback about mentorship and TM
timeFrame: 52 weeks
measure: Participant knowledge about CAD
timeFrame: 52 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: HeartHealth - Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jessica M Peña, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: