Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03020316
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2015-10-26
Brief Title:
Peer Mentored Approaches For Men And Women With Coronary Artery Disease 4Steps
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Peer Mentored Approaches For Men And Women With Coronary Artery Disease 4Steps
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None