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

August 21, 2023 updated by: The Hearthstone Institute, LLC

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!

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
        • The Hearthstone Institute, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.
No Intervention: No Intervention: Control, Standard Care / Programming
Participants in the Control arm will receive standard care / programming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menorah Park Engagement Scale
Time Frame: 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
Baseline--that is, week 1 thru week 4
Menorah Park Engagement Scale
Time Frame: 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
Treatment--that is, during week 5 thru week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dementia Related Quality of Life (DEMQOL)
Time Frame: 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.
Baseline--that is, week 1 thru week 4
Dementia Related Quality of Life (DEMQOL)
Time Frame: 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.
Post-Treatment--that is during week 23 thru week 24
Geriatric Depression Scale-Short Form
Time Frame: 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.
Baseline--that is, week 1 thru week 4
Geriatric Depression Scale-Short Form
Time Frame: 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.
Post-Treatment--that is during week 23 thru week 24
Neuropsychiatric Inventory - Nursing Home
Time Frame: 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.
Baseline--that is, week 1 thru week 4
Neuropsychiatric Inventory - Nursing Home
Time Frame: 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.
Post-Treatment--that is during week 23 thru week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hearthstone Institute, LLC

Investigators

  • Principal Investigator: Michael Skrajner, MA, Hearthstone

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2020

Primary Completion (Actual)

June 11, 2023

Study Completion (Actual)

June 11, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG059443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on LEAD IT! Programming

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe