HeartHealth - Weill Cornell Medical College
New York, 10021, United States
NCT Number: NCT03020316
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
New York, 10021, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Participants:
For Mentors:
(Male mentors will be paired with male participants, and female mentors will be paired with female participants.)
Exclusion criteria
For Participants:
For Mentors:
A volunteer with a similar disease as the subject
A meditation technique
Time frame: 52 weeks
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
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
Visual analog scale for medication adherence
Total scale range: 0-100%. Higher percentage indicates better adherence.
Time frame: 52 weeks
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
Height (m)
Time frame: 52 weeks
Weight (kg)
Time frame: 52 weeks
Blood pressure (mmHg)
Time frame: 52 weeks
Heart rate (beats/min)
Time frame: 52 weeks
Waist circumference (cm)
Time frame: 52 weeks
Total cholesterol, LDL, HDL, triglycerides (mg/dL)
Time frame: 52 weeks
Fasting plasma glucose levels (mg/dL)
Time frame: 52 weeks
Was the subject readmitted or not
Time frame: 52 weeks
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
Verbal description
Time frame: 52 weeks
Verbal description
Time frame: 52 weeks
Verbal description
Weill Medical College of Cornell University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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