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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Peer Mentor; Behavioral: Transcendental Meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • HeartHealth - Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Behavioral: Peer Mentor; A volunteer with a similar disease as the subject; Behavioral: Transcendental Meditation; A meditation technique
Active Comparator: 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.	Behavioral: Peer Mentor; A volunteer with a similar disease as the subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	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.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence (ARMS-7)	Adherence to Refills and Medication Scale (ARMS-7) Total scale range: 7-28; subscale range: 1-4. Scores can be treated as a continuous measure or dichotomized as 7 or >7. Lower scores indicate better adherence.	52 weeks
Medication Adherence (VAS)	Visual analog scale for medication adherence Total scale range: 0-100%. Higher percentage indicates better adherence.	52 weeks
Depressive Symptoms	Center for Epidemiologic Studies Depression Scale (CES-D) Total scale range: 0-60. Total score of 16 or higher is considered depressed.	52 weeks
Height	Height (m)	52 weeks
Weight	Weight (kg)	52 weeks
Blood pressure	Blood pressure (mmHg)	52 weeks
Heart rate	Heart rate (beats/min)	52 weeks
Waist circumference	Waist circumference (cm)	52 weeks
Lipid panel results	Total cholesterol, LDL, HDL, triglycerides (mg/dL)	52 weeks
Fasting plasma glucose	Fasting plasma glucose levels (mg/dL)	52 weeks
Hospital readmission	Was the subject readmitted or not	52 weeks
Changes in physical activity	Measured by International Physical Activity Questionnaire (IPAQ) Survey does not include a range of possible values. Based on verbal description of activity and participation time, populations are divided into 3 proposed levels of physical activity: inactive, minimally active, and HEPA active.	52 weeks
Number and manner of contacts between participants and mentors	Verbal description	52 weeks
Participant feedback about mentorship and TM	Verbal description	52 weeks
Participant knowledge about CAD	Verbal description	52 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Jessica M Peña, MD, MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 6, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 1507016382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No