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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020316
• Other study ID #: 1507016382
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 22, 2019

Study information

• Verified date: November 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 22, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Peer Mentor
A volunteer with a similar disease as the subject
• Transcendental Meditation
A meditation technique

Locations

Country	Name	City	State
United States	HeartHealth - Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Medication Adherence (VAS)	Visual analog scale for medication adherence; Total scale range: 0-100%. Higher percentage indicates better adherence.	52 weeks
Secondary	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
Secondary	Height	Height (m)	52 weeks
Secondary	Weight	Weight (kg)	52 weeks
Secondary	Blood pressure	Blood pressure (mmHg)	52 weeks
Secondary	Heart rate	Heart rate (beats/min)	52 weeks
Secondary	Waist circumference	Waist circumference (cm)	52 weeks
Secondary	Lipid panel results	Total cholesterol, LDL, HDL, triglycerides (mg/dL)	52 weeks
Secondary	Fasting plasma glucose	Fasting plasma glucose levels (mg/dL)	52 weeks
Secondary	Hospital readmission	Was the subject readmitted or not	52 weeks
Secondary	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
Secondary	Number and manner of contacts between participants and mentors	Verbal description	52 weeks
Secondary	Participant feedback about mentorship and TM	Verbal description	52 weeks
Secondary	Participant knowledge about CAD	Verbal description	52 weeks