PRogram to Improve Stress-levels and Enhance Memory (NCT05845918) | Clinical Trial Compass
CompletedNot Applicable
PRogram to Improve Stress-levels and Enhance Memory
United States45 participantsStarted 2023-02-21
Plain-language summary
This is a pilot study with the objective to examine if an in-person and a remote multi-component intervention program can improve chronic stress, vascular measures, and executive function among African American and White patients with Mild Cognitive Impairment. Researchers plan to enroll 45 participants with over-recruitment of African American patients. Participants will be recruited to participate in PRogram to Improve Stress-levels and Enhance Memory (PRISEM) (i.e., remote lifestyle intervention program). The participants will be asked to participate in group-based and/or individual activities that focus on improving health education, nutrition, physical activity, cognitive health, stress levels, and overall well-being. The duration of the study for all participants will be 12 months with 3 study visits. At each study visit, the following measures will be assessed: psychosocial, behavioral, vascular/physical, and executive function.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 50 years or older
* Fluency in English
* African American or White
* MCI will be defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) 19- 25
* Prior diagnosis of MCI
* Participants would be sedentary at baseline (self-report of \<30 minutes of structured physical activity \<3 times per week in the last 6 months) and have poor Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet scores (using the MIND diet screener)
Exclusion Criteria:
* Dementia diagnosis or reversible causes of dementia (e.g., if the patient has hypothyroidism or low vitamin B12 that is contributing to the subject's cognitive impairment)
* Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study (e.g., actively manic patient)
* Uncontrolled medical conditions, such as congestive heart failure, reflected by poor exercise tolerance and shortness of breath
* Any physical ailment, such as stroke with residual impairment, that is a barrier to performing study procedures and attending sessions
* History of brain lesions, stroke, or major head trauma in the past year
* Those who are unable to demonstrate that they understood the details of the study (i.e., lack of decisional- capacity to consent) or linguistic limitations
* Pregnant women, prisoners, and adults unable to consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility for the PRISEM pilot to collect additional stress and vascular measurements
Timeframe: 6 months
2
Acceptability for the PRISEM pilot to collect additional stress and vascular measures.