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DEMA Intervention for Mild Cognitive Impairment (PRIMA Trial)

Led By Yvonne Y Lu, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
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);
Screening 3 weeks
Treatment Varies
Follow Up change from baseline dds at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
Awards & highlights

PRIMA Trial Summary

This trial is testing whether the DEMA intervention can improve life satisfaction and health outcomes for patients and caregivers, compared to the attention control group.

Who is the study for?
This trial is for pairs of adults over 59 with mild cognitive impairment (MCI) and their caregivers. Participants need to speak English, be oriented in time and space, have a phone, and not require help with daily tasks. Caregivers must be adults providing unpaid care without severe cognitive issues themselves.Check my eligibility
What is being tested?
The study tests the DEMA program against an information support group. DEMA aims to improve life satisfaction by helping patients/caregivers identify meaningful activities and learn about MCI through sessions with a nurse.See study design
What are the potential side effects?
Since this intervention involves educational activities rather than medication, typical drug side effects are not expected. However, participants may experience emotional or psychological responses to discussing MCI-related topics.

PRIMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am over 18, care for someone with MCI, speak English, and am mentally oriented.
I am over 59, speak English, have memory concerns, a MoCA score of 15-25, and can do daily tasks without help.

PRIMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline copm at session 1(at week 1), session 2(at week 2), session 3 (at week 4), session 4 (at week 6), session 5 (at week 8), session 6 (at week 10); session 7 (at week 12), 10 days post-, 3 months post-, and 6 months-post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline copm at session 1(at week 1), session 2(at week 2), session 3 (at week 4), session 4 (at week 6), session 5 (at week 8), session 6 (at week 10); session 7 (at week 12), 10 days post-, 3 months post-, and 6 months-post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Life satisfaction
Secondary outcome measures
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
Caregiving Outcomes Scale (COS)
Patient Health Questionnaire-9 Items (PHQ-9)
+2 more
Other outcome measures
Confidence Scale
Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions)
Demographic Profile and Comorbidity Condition
+8 more

PRIMA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Daily Engagement Meaningful Activity (DEMA)Experimental Treatment1 Intervention
This group will receive 7 individualized sessions, 1 face-to-face session at week 1 and via 6 bi weekly telephone sessions delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.
Group II: Information Support (IS)Placebo Group1 Intervention
This group will attend 1 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer disease educational brochure from the Alzheimer's Association (AA). The face-to-face sessions will take place at the IADC Clinical Core clinic, Indiana University Center of Excellence of Women's Health clinic, or Indiana School of Nursing conference room that based on patient-caregiver dyad's preference. Then they will receive 6 bi weekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.

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Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,375,982 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,760 Total Patients Enrolled
Yvonne Y Lu, PhDPrincipal InvestigatorIndiana University School of Medicine

Media Library

Daily Engagement Meaningful Activity (DEMA) Clinical Trial Eligibility Overview. Trial Name: NCT04515875 — N/A
Mild Cognitive Impairment Research Study Groups: Information Support (IS), Daily Engagement Meaningful Activity (DEMA)
Mild Cognitive Impairment Clinical Trial 2023: Daily Engagement Meaningful Activity (DEMA) Highlights & Side Effects. Trial Name: NCT04515875 — N/A
Daily Engagement Meaningful Activity (DEMA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515875 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been approved for this research project?

"Affirmative. According to the information on clinicaltrials.gov, this experiment was initially posted on December 13th 2021 and is actively searching for suitable candidates with a goal of 400 patients at one site. The trial has been updated as recently as October 21st 2022."

Answered by AI

Is there a possibility that I could participate in this research endeavor?

"Qualified individuals should present with mild cognitive impairment (MCI) and be aged between 18-100. At this time, the trial is looking to recruit around 400 participants."

Answered by AI

Is this trial actively seeking new participants?

"This trial, which was initially made available on December 13th 2021 and has most recently been updated October 21st 2022, is actively searching for potential participants."

Answered by AI

Is the study open to applicants younger than 75 years old?

"The recruitment effort for this medical trial calls out to individuals aged 18 and above, up until the age of 100."

Answered by AI
Recent research and studies
~133 spots leftby Jun 2025