Status:
COMPLETED
PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 positiv...
Detailed Description
Approximately 20% of Americans over 65 have mild cognitive impairment (MCI), defined as experiencing more memory problems than normally expected with aging, but no other symptoms of dementia such as i...
Eligibility Criteria
Inclusion
- Both the MCI patient and caregiver must consent to participate and have a phone at home or daily access to a telephone to be eligible for the study.
- MCI patients will be eligible, if they:
- are aged \> 59 years old;
- able to speak and read English;
- have both self or informant reported cognitive complaints,
- have MoCA score = 15 to 25
- are 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);
- Family caregivers (spouse, other family members or friends) will be eligible, if they
- self-identify as care partner
- are aged ≥ 18 years old,
- have primary responsibility for providing unpaid care to an MCI patient, along with monitoring safety and providing social support;
- are able to speak and read English;
- are oriented to persons, places, and time (having a 6-item Screener score of 4 or above).
Exclusion
- MCI patients and family caregivers will be excluded, if the MCI patient or family caregiver dyads participants are:
- 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).
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04515875
Start Date
December 13 2021
End Date
July 20 2025
Last Update
July 31 2025
Active Locations (1)
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1
Indiana University Alzhemier Disease Research Center
Indianapolis, Indiana, United States, 46202