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

Primary Purpose

Dementia, Vascular, Alzheimer Disease, Dementia, Mixed

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LEAD IT! Programming
Sponsored by
The Hearthstone Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Vascular focused on measuring psychosocial, social, non-pharmacological intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hearthstone Institute, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Experimental, LEAD IT! Programming

No Intervention: Control, Standard Care / Programming

Arm 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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
Geriatric Depression Scale-Short Form
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Geriatric Depression Scale-Short Form
This is a 15-item measure of depression in older adults that is conducted via direct interview.
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.
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.

Full Information

First Posted
August 10, 2022
Last Updated
August 21, 2023
Sponsor
The Hearthstone Institute, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05516342
Brief Title
LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Official Title
LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
June 11, 2023 (Actual)
Study Completion Date
June 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearthstone Institute, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
Keywords
psychosocial, social, non-pharmacological intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Experimental, LEAD IT! Programming
Arm Type
Experimental
Arm 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.
Arm Title
No Intervention: Control, Standard Care / Programming
Arm Type
No Intervention
Arm Description
Participants in the Control arm will receive standard care / programming.
Intervention Type
Behavioral
Intervention Name(s)
LEAD IT! Programming
Intervention Description
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
Primary Outcome Measure Information:
Title
Menorah Park Engagement Scale
Description
The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure
Time Frame
Baseline--that is, week 1 thru week 4
Title
Menorah Park Engagement Scale
Description
The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure
Time Frame
Treatment--that is, during week 5 thru week 22
Secondary Outcome Measure Information:
Title
Dementia Related Quality of Life (DEMQOL)
Description
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.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Dementia Related Quality of Life (DEMQOL)
Description
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.
Time Frame
Post-Treatment--that is during week 23 thru week 24
Title
Geriatric Depression Scale-Short Form
Description
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Geriatric Depression Scale-Short Form
Description
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Time Frame
Post-Treatment--that is during week 23 thru week 24
Title
Neuropsychiatric Inventory - Nursing Home
Description
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Neuropsychiatric Inventory - Nursing Home
Description
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.
Time Frame
Post-Treatment--that is during week 23 thru week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Skrajner, MA
Organizational Affiliation
Hearthstone
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hearthstone Institute, LLC
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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