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

NCT ID: NCT03020316

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-11-22

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Peer Mentor

Intervention Type: BEHAVIORAL

A volunteer with a similar disease as the subject

Transcendental Meditation

Intervention Type: BEHAVIORAL

A meditation technique

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.

Group Type: ACTIVE_COMPARATOR

Peer Mentor

Intervention Type: BEHAVIORAL

A volunteer with a similar disease as the subject

Interventions

Peer Mentor

A volunteer with a similar disease as the subject

Intervention Type: BEHAVIORAL

Transcendental Meditation

A meditation technique

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica M Peña, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

HeartHealth - Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

1507016382

Identifier Type: -

Identifier Source: org_study_id