LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
NCT ID: NCT05516342
Last Updated: 2024-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
182 participants
INTERVENTIONAL
2020-11-10
2023-06-11
Brief Summary
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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!
Detailed Description
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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. During Months 1-7, the Beta 1 version of the app will be created by the study's Development Team (DT). During Months 13-15, the DT will create an improved Beta 2 version, based on lessons learned in Beta 1 testing.
2. Examine the extent to which RLs are able to serve as leaders while using LEAD IT! During all intervention sessions, researchers will track the extent to which each RL follows key steps involved in leading each activity. RLs will be considered successful if they follow the steps 80% of the time and require less staff assistance on less than 20% of steps.
3. Examine the effects of resident-led LEAD IT! programming on RPs. Two quasi-experiments will be conducted. Experiment #1, which will test the Beta 1 version of LEAD IT!, will use a pre-post design. Proximal (immediate) effects will be assessed by examining RP's levels of engagement/affect during baseline (standard) activities and again during LEAD IT! activities. It is hypothesized that LEAD IT! will result in higher quality engagement than baseline activities. Experiment #2, which will test the Beta 2 version of the app, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of a Treatment Group (TG)-which will consist of PWD who receive the intervention - and a Control Group (CG) - which will consist of PWD who receive standard programming / care. Since Experiment #2 will occur after all improvements to the app have been made, it will represent the definitive trial of the LEAD IT! app's impact on PWD. For proximal (immediate) measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in positive forms of engagement, as compared to CG participants. For distal measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in quality of life (based upon the DEMQOL) at treatment, as compared to CG participants.
4. Examine PWD and staff satisfaction with LEAD IT! This will be achieved by eliciting feedback from PWD and staff members. PWD and staff members will be considered "highly satisfied" with the app if 85% are satisfied with the app.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Experimental, LEAD IT! Programming
Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 18 weeks. The programming will occur twice per week, for a total of 36 sessions.
LEAD IT! Programming
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
No Intervention: Control, Standard Care / Programming
Participants in the Control arm will receive standard care / programming.
No interventions assigned to this group
Interventions
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LEAD IT! Programming
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
Eligibility Criteria
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Inclusion Criteria
* 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
* Must be at least 18 years old
* Must speak English
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hopeful Aging
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Skrajner, MA
Role: PRINCIPAL_INVESTIGATOR
Hearthstone
Locations
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The Hearthstone Institute, LLC
Winchester, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AG059443
Identifier Type: -
Identifier Source: org_study_id
NCT04899973
Identifier Type: -
Identifier Source: nct_alias