LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Study Details
Study Description
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:
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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.
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Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
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Examine the effects of resident-led LEAD IT! programming on RPs.
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Examine PWD and staff satisfaction with LEAD IT!
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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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.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
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| No Intervention: No Intervention: Control, Standard Care / Programming Participants in the Control arm will receive standard care / programming. |
Outcome Measures
Primary Outcome Measures
- Menorah Park Engagement Scale [Baseline--that is, week 1 thru week 4]
The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure
- Menorah Park Engagement Scale [Treatment--that is, during week 5 thru week 22]
The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure
Secondary Outcome Measures
- Dementia Related Quality of Life (DEMQOL) [Baseline--that is, week 1 thru week 4]
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.
- Dementia Related Quality of Life (DEMQOL) [Post-Treatment--that is during week 23 thru week 24]
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.
- Geriatric Depression Scale-Short Form [Baseline--that is, week 1 thru week 4]
This is a 15-item measure of depression in older adults that is conducted via direct interview.
- Geriatric Depression Scale-Short Form [Post-Treatment--that is during week 23 thru week 24]
This is a 15-item measure of depression in older adults that is conducted via direct interview.
- Neuropsychiatric Inventory - Nursing Home [Baseline--that is, week 1 thru week 4]
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.
- Neuropsychiatric Inventory - Nursing Home [Post-Treatment--that is during week 23 thru week 24]
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.
Eligibility Criteria
Criteria
Inclusion Criteria for Persons with Dementia
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Must reside in an Assisted Living Facility or NH
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Must be at least 65 years old
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Must speak and read English
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Must have a clinical diagnosis of dementia (any type).
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Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
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Resident-leaders must score at least 13 on the MMSE
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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
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Must be at least 18 years old
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Must speak English
Exclusion Criteria for Staff
-n/a
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hearthstone Institute, LLC | Winchester | Massachusetts | United States | 01890 |
Sponsors and Collaborators
- The Hearthstone Institute, LLC
Investigators
- Principal Investigator: Michael Skrajner, MA, Hearthstone
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AG059443