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NCT04515875 · ClinicalTrials.gov registry record · NA
PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 420
- Enrollment target
NCT04515875: Completed NA study, sponsored by Indiana University.
NCT04515875 is a NA study that has completed, run by Indiana University. The registered enrollment target is 420 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04515875, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
Study 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 200 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
Primary Outcome
The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 20
Interventions
- BEHAVIORAL Information Support (IS)
- BEHAVIORAL Daily Engagement Meaningful Activity (DEMA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2025-07-20 |
| Phase | NA |
What the finished NCT04515875 record still lists
NCT04515875 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Information Support (IS) is the first listed.
NCT04515875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04515875 about?
NCT04515875 is a clinical study titled "PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers". 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. Ove...
What is the current status of trial NCT04515875?
This trial is currently completed. It is a NA study. The enrollment target is 420 participants. The study started on 2021-12-13. Estimated completion is 2025-07-20.
What interventions are being tested in trial NCT04515875?
The interventions under investigation include: Information Support (IS) (BEHAVIORAL), Daily Engagement Meaningful Activity (DEMA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04515875?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04515875's enrollment target sits among peer trials
420 239th of 2000 higher than 1,761 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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