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

Study Overview
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Brief Summary
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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!

Detailed Description
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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.

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

Conditions
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Dementia, Vascular, Alzheimer Disease, Dementia, Mixed

Intervention / Treatment
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* Behavioral: LEAD IT! Programming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Experimental, LEAD IT! Programming<br>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. | Behavioral: LEAD IT! Programming<br>* LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.<br>|
| No Intervention: No Intervention: Control, Standard Care / Programming<br>Participants in the Control arm will receive standard care / programming. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menorah Park Engagement Scale | The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure | Baseline--that is, week 1 thru week 4 | 
| Menorah Park Engagement Scale | The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure | Treatment--that is, during week 5 thru week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia Related Quality of Life (DEMQOL) | The Dementia Related Quality of Life measures quality of life in persons with dementia. There is a direct interview and proxy version. The DEMQOL is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration. The DEMQOL-Proxy is a 31-item test completed by the caretaker and focuses on cognition, negative emotion, positive emotion, daily activities, and appearance. The DEMQOL can be completed by patients with mild to moderate dementia. Whereas the DEMQOL-Proxy is completed by a caregiver for individuals with mild, moderate, or severe dementia. In one study, an early version of the DEMQOL was used and included other inclusion criteria such as ability to communicate and understand others, no major illnesses or disabilities, and able to communicate in English. | Baseline--that is, week 1 thru week 4 | 
| Dementia Related Quality of Life (DEMQOL) | The Dementia Related Quality of Life measures quality of life in persons with dementia. There is a direct interview and proxy version. The DEMQOL is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration. The DEMQOL-Proxy is a 31-item test completed by the caretaker and focuses on cognition, negative emotion, positive emotion, daily activities, and appearance. The DEMQOL can be completed by patients with mild to moderate dementia. Whereas the DEMQOL-Proxy is completed by a caregiver for individuals with mild, moderate, or severe dementia. In one study, an early version of the DEMQOL was used and included other inclusion criteria such as ability to communicate and understand others, no major illnesses or disabilities, and able to communicate in English. | Post-Treatment--that is during week 23 thru week 24 | 
| Geriatric Depression Scale-Short Form | This is a 15-item measure of depression in older adults that is conducted via direct interview. | Baseline--that is, week 1 thru week 4 | 
| Geriatric Depression Scale-Short Form | This is a 15-item measure of depression in older adults that is conducted via direct interview. | Post-Treatment--that is during week 23 thru week 24 | 
| Neuropsychiatric Inventory - Nursing Home | The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes. | Baseline--that is, week 1 thru week 4 | 
| Neuropsychiatric Inventory - Nursing Home | The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes. | Post-Treatment--that is during week 23 thru week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial, social, non-pharmacological intervention