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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516342
• Other study ID #: AG059443
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: June 11, 2023

Study information

• Verified date: August 2023
• Source: The Hearthstone Institute, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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!

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.

Other known NCT identifiers

• NCT04899973

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 11, 2023
• Est. primary completion date: June 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Mixed
• Dementia, Vascular

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Hearthstone Institute, LLC	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The Hearthstone Institute, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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