Clinical trial NCT05516342: LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Official title: LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Vascular
Alzheimer Disease
Dementia, Mixed
Keywords: psychosocial
social
non-pharmacological intervention
Lead sponsor: Hopeful Aging
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two quasi-experiments will be conducted. Experiment #1 will test the Beta 1 Version of the app with 24 PWD and use a pre-post design. Experiment #1's goal is to examine and improve new activities and to make final changes to the overall app structure. Experiment #2, which will test Beta 2, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of two nonequivalent groups: a Treatment Group (TG)-i.e. 48 PWD who receive the intervention - and a Control Group (CG)- i.e., 48 PWD receiving standard programming / care. Since Experiment #2 will occur after all tweaking is complete, it will represent the definitive trial of LEAD IT!'s proximal and distal effects.
Primary purpose: TREATMENT

Brief 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!

Detailed description: he proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, as well as examine the clinical outcomes of long-term use of the app by both RLs and 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. 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.

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

Primary outcomes:
measure: 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)
timeFrame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
measure: Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
measure: Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
measure: Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
measure: Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
timeFrame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Secondary outcomes:
measure: Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
timeFrame: Baseline (Month 1) and Post-Treatment (Month 4)
measure: Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
timeFrame: Baseline (Month 1) and Post-Treatment (Month 4)
measure: Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: Baseline (Month 1) and Post-Treatment (Month 4)
measure: Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)
timeFrame: Baseline (Month 1) and Post-Treatment (Month 4)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: The Hearthstone Institute, LLC
state: Massachusetts
Study officials:
affiliation: Hearthstone
name: Michael Skrajner, MA
role: PRINCIPAL_INVESTIGATOR
References: