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NCT05516342 · ClinicalTrials.gov registry record · NA
LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
A NA study of Alzheimer Disease and Dementia, Vascular, sponsored by Hopeful Aging.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
- 1
- Study location
NCT05516342: Completed NA study of Alzheimer Disease and Dementia, Vascular, sponsored by Hopeful Aging.
NCT05516342 is a NA study of Alzheimer Disease and Dementia, Vascular that has completed, run by Hopeful Aging. The registered enrollment target is 182 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05516342, a NA study of Alzheimer Disease and Dementia, Vascular, has completed, sponsored by Hopeful Aging.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs). The Specific Aims of the proposed Phase 2 project are to: 1. Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. 2. Examine the extent to which RLs are able to serve as leaders while using LEAD IT! 3. Examine the effects of resident-led LEAD IT! programming on RPs. 4. Examine PWD and staff satisfaction with LEAD IT!
Primary Outcome
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for C
Conditions Studied
Interventions
- BEHAVIORAL LEAD IT! Programming
Study Locations (1)
Massachusetts
- The Hearthstone Institute, LLC - Winchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2023-06-11 |
| Phase | NA |
What the finished NCT05516342 record still lists
NCT05516342 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which LEAD IT! Programming is the first listed.
NCT05516342 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05516342 about?
NCT05516342 is a clinical study titled "LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers". The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of ...
What is the current status of trial NCT05516342?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2020-11-10. Estimated completion is 2023-06-11.
What conditions does trial NCT05516342 study?
This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Vascular, Dementia, Mixed.
What interventions are being tested in trial NCT05516342?
The interventions under investigation include: LEAD IT! Programming (BEHAVIORAL).
Who is sponsoring clinical trial NCT05516342?
This trial is sponsored by Hopeful Aging, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05516342 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05516342's enrollment target sits among peer trials
182 116th of 306 higher than 190 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
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