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LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
NCT05516342 · View on ClinicalTrials.gov ↗
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!
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05516342
The ClinicalTrials.gov registry entry for NCT05516342 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hopeful Aging, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05516342 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05516342?
The interventions under investigation include: LEAD IT! Programming (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05516342?
This trial is sponsored by Hopeful Aging, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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