LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers

Hopeful Aging

Status

Completed

Conditions

Alzheimer Disease

Dementia, Vascular

Dementia, Mixed

Treatments

Behavioral: LEAD IT! Programming

Study type

Interventional

Funder types

Industry

Identifiers

NCT05516342

AG059443

Details and patient eligibility

About

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:

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.
Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
Examine the effects of resident-led LEAD IT! programming on RPs.
Examine PWD and staff satisfaction with LEAD IT!

Full 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:

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.
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.
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.
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.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

182 participants in 2 patient groups

Experimental: Experimental, LEAD IT! Programming

Experimental group

Description:

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.

Treatment:

Behavioral: LEAD IT! Programming

No Intervention: Control, Standard Care / Programming

No Intervention group

Description:

Participants in the Control arm will receive standard care / programming.

Trial documents