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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Mentor
Transcendental Meditation
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HeartHealth - Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Usual Care

Peer Mentor & Transcendental Meditation

Peer Mentor

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Medication Adherence (VAS)
Visual analog scale for medication adherence Total scale range: 0-100%. Higher percentage indicates better adherence.
Depressive Symptoms
Center for Epidemiologic Studies Depression Scale (CES-D) Total scale range: 0-60. Total score of 16 or higher is considered depressed.
Height
Height (m)
Weight
Weight (kg)
Blood pressure
Blood pressure (mmHg)
Heart rate
Heart rate (beats/min)
Waist circumference
Waist circumference (cm)
Lipid panel results
Total cholesterol, LDL, HDL, triglycerides (mg/dL)
Fasting plasma glucose
Fasting plasma glucose levels (mg/dL)
Hospital readmission
Was the subject readmitted or not
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.
Number and manner of contacts between participants and mentors
Verbal description
Participant feedback about mentorship and TM
Verbal description
Participant knowledge about CAD
Verbal description

Full Information

First Posted
October 26, 2015
Last Updated
November 25, 2019
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03020316
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Peer Mentor & Transcendental Meditation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Peer Mentor
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Mentor
Intervention Description
A volunteer with a similar disease as the subject
Intervention Type
Behavioral
Intervention Name(s)
Transcendental Meditation
Intervention Description
A meditation technique
Primary Outcome Measure Information:
Title
Perceived Stress
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Medication Adherence (ARMS-7)
Description
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.
Time Frame
52 weeks
Title
Medication Adherence (VAS)
Description
Visual analog scale for medication adherence Total scale range: 0-100%. Higher percentage indicates better adherence.
Time Frame
52 weeks
Title
Depressive Symptoms
Description
Center for Epidemiologic Studies Depression Scale (CES-D) Total scale range: 0-60. Total score of 16 or higher is considered depressed.
Time Frame
52 weeks
Title
Height
Description
Height (m)
Time Frame
52 weeks
Title
Weight
Description
Weight (kg)
Time Frame
52 weeks
Title
Blood pressure
Description
Blood pressure (mmHg)
Time Frame
52 weeks
Title
Heart rate
Description
Heart rate (beats/min)
Time Frame
52 weeks
Title
Waist circumference
Description
Waist circumference (cm)
Time Frame
52 weeks
Title
Lipid panel results
Description
Total cholesterol, LDL, HDL, triglycerides (mg/dL)
Time Frame
52 weeks
Title
Fasting plasma glucose
Description
Fasting plasma glucose levels (mg/dL)
Time Frame
52 weeks
Title
Hospital readmission
Description
Was the subject readmitted or not
Time Frame
52 weeks
Title
Changes in physical activity
Description
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.
Time Frame
52 weeks
Title
Number and manner of contacts between participants and mentors
Description
Verbal description
Time Frame
52 weeks
Title
Participant feedback about mentorship and TM
Description
Verbal description
Time Frame
52 weeks
Title
Participant knowledge about CAD
Description
Verbal description
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Peña, MD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HeartHealth - Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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