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

NCT03020316 | Completed

• 1 other identifier: 1507016382
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Medication Adherence (ARMS-7)

  52 weeks

• Medication Adherence (VAS)

  52 weeks

• Depressive Symptoms

  52 weeks

• Height

  52 weeks

• Weight

  52 weeks

Study Arms (3)

Usual Care

NO INTERVENTION

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

ACTIVE COMPARATOR

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; Behavioral: Transcendental Meditation

Peer Mentor

ACTIVE COMPARATOR

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

Interventions

Peer Mentor BEHAVIORAL

A volunteer with a similar disease as the subject

Peer Mentor; Peer Mentor & Transcendental Meditation

Transcendental Meditation BEHAVIORAL

A meditation technique

Peer Mentor & Transcendental Meditation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

HeartHealth - Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Meditation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica M Peña, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: January 13, 2017
• Study Start: April 1, 2016
• Primary Completion: October 6, 2019
• Study Completion: November 22, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

US (1)