PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers (NCT04515875) | Clinical Trial Compass
CompletedNot Applicable
PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
United States420 participantsStarted 2021-12-13
Plain-language summary
The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes for patients and caregivers. DEMA is a positive health focused, theoretically grounded, tailored, family-centered, multi-faceted intervention. Over 7 session, dyads work with a nurse to 1) identify meaningful activities, assess capacity, problem-solve barriers, and establish routines for engagement and 2) learn more about MCI by working through six Self-Management Toolkit topics (e.g., benefits of meaningful activity; planning the future). The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
Who can participate
Age range
18 Years – 100 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: MCI Patient
* age greater than 59 years old
* able to speak and read English
* access to telephone
* have both self or informant reported cognitive complaints
* MoCA score = 15 to 25
* in the normal range in performance of daily living tasks based on functional impairment absent: a check box of Functional Activities Questionnaire (FAQ) has no score ≥2);
Inclusion Criteria: Family caregivers:
* self-identify as care partner (i.e. spouse, family member or friend)
* aged greater than or equal to 18 years
* have primary responsibility for providing care to an MCI patient, along with monitoring safety and providing social support;
* are able to speak and read English;
* access to telephone
* oriented to persons, places, and time (having a 6-item Screener score of 4 or above).
Exclusion Criteria:
* a diagnosed untreated severe major depression, or receiving advanced cancer treatment or hospice care
* receiving dialysis
* severe hearing loss and no hearing aids
* have no access to a telephone
* the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE \< 4).
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
Life Satisfaction (LSITA)
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation