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: Recruiting

Administrative data

• NCT number: NCT04899973
• Other study ID #: AG059443
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2021
• Source: Hearthstone Alzheimer Care
• Contact: Michael Skrajner, MA
• Phone: 4404777881
• Email: skrajner[@]thehearth.org
• 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:

Approximately one million persons with dementia (PWD) reside in long term care (LTC), and this figure is expected to double over the next 20 years. Dementia interferes with a person's ability to function independently and is also associated with a variety of responsive behaviors. In fact, researchers have found that 97% of PWD exhibit at least one challenging behavior over the course of a five-year period. Persons with early stage dementia (PESD) also often experience an existential crisis, as they feel a loss of purpose in life. While the remaining strengths of PESD have been known for some time, few opportunities for meaningful social roles exist. So, there is an urgent need to create interventions that enable PESD to fill such roles and capitalize on their many remaining skills.

The product under consideration in this project addresses this critical need through the use of an evidence-based, resident-led group activity program. Since many PESD reside in LTC, the role of group activity leader is a sensible option for providing a meaningful social role. To this end, the Principal Investigator of this project managed two studies in which PESD served as group activity leaders for other PWD. These studies demonstrated that (1) PESD can successfully serve as activity leaders if appropriate materials/processes are used; (2) resident-led programming produced higher levels of positive engagement than staff-led activities-i.e., PESD were more effective than staff; (3) minimal training is needed for the resident-leaders (RLs) and all training must occur "on the floor"; (4) leaders found the roles meaningful; and (5) responsive behaviors were reduced in some leaders. In these studies, resident-led activities materials were hard-copy (paper-based) in nature. Despite the positive outcomes, resident-led programming was never commercialized or disseminated on a large scale, largely due to the hard-copy (printed) nature of the activity materials.

Given the success of resident-led programming, the increased prevalence of dementia, and the push for early detection of dementia, there is an urgent need and strong commercialization potential for a product that enables PESD to serve as group leaders in resident-led activities. Since high-speed internet, tablets, and apps have become ubiquitous, one promising way to deploy such a product is through a tablet-based app. With this in mind, in a Phase 1 SBIR, the Principal Investigator of this project developed and evaluated an Alpha Version of a tablet-based app called LEAD IT!, which enables PESD to implement resident-led activities. The Phase 1 project demonstrated that (1) PESD were capable of using the app to facilitate activities, (2) PWD participating in such activities-i.e., resident-players (RPs)-exhibited high levels of positive engagement, and (3) both RLs and RPs reported high satisfaction with the app. The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: August 31, 2022
• Est. primary completion date: August 30, 2022
• 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

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	Hearthstone Alzheimer Care	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hearthstone Alzheimer Care

Country where clinical trial is conducted

United States, 

References & Publications (3)

Camp CJ, Skrajner MJ. Resident-Assisted Montessori Programming (RAMP): training persons with dementia to serve as group activity leaders. Gerontologist. 2004 Jun;44(3):426-31. — View Citation

Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. Review. — View Citation

Skrajner MJ, Haberman JL, Camp CJ, Tusick M, Frentiu C, Gorzelle G. Effects of using nursing home residents to serve as group activity leaders: lessons learned from the RAP project. Dementia (London). 2014 Mar 1;13(2):274-85. doi: 10.1177/1471301213499219. Epub 2013 Aug 27. — View Citation

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
Primary	Dementia Related Quality of Life	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 4
Primary	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	Cohen Mansfield Agitation Inventory	The Cohen-Mansfield Agitation Inventory is a scale intended to systematically assess agitation in older adults.	Baseline--that is, week 1 thru week 4
Secondary	Cohen Mansfield Agitation Inventory	The Cohen-Mansfield Agitation Inventory is a scale intended to systematically assess agitation in older adults.	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.