N/A
Completed N=95
LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Dementia, Vascular · Alzheimer's Disease · Dementia, Mixed
Source: ClinicalTrials.gov NCT05516342 ↗
Enrolled (actual)
95
Serious AEs
11.6%
Results posted
Dec 2024
Primary outcomePrimary: Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4) — 0.19; -0.24 score on a scale — p=<0.01
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!
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
0.19; -0.24 | <0.01 sig |
| PRIMARY Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale |
0.69; -0.12 | <0.01 sig |
| PRIMARY Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale |
-0.32; 0.28 | <0.01 sig |
| PRIMARY Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale |
-.24; 0.02 | <0.01 sig |
| PRIMARY Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale |
0.32; -0.02 | <0.01 sig |
| SECONDARY Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL) |
1.51; 1.08 | 0.89 |
| SECONDARY Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS) |
-0.15; 3.06 | 0.27 |
| SECONDARY Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF) |
-0.71; 0.38 | 0.19 |
| SECONDARY Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI) |
-0.21; 2.00 | 0.10 |
Eligibility Criteria
Inclusion Criteria for Persons with Dementia
- Must reside in an Assisted Living Facility or NH
- Must be at least 65 years old
- Must speak and read English
- Must have a clinical diagnosis of dementia (any type).
- Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
- Resident-leaders must score at least 13 on the MMSE
- Resident-leaders must possess at least 70% of the characteristics of successful leaders, based upon the I'm Still Here Skills Inventory, Short Edition, Modified
Exclusion Criteria for Persons with Dementia -the person shows signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.
Inclusion Criteria for Staff
- Must be at least 18 years old
- Must speak English
Exclusion Criteria for Staff
-n/a
Data sourced from ClinicalTrials.gov (NCT05516342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.