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

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: Alzheimer Disease; Dementia, Vascular; Dementia, Mixed
• Intervention / Treatment: Behavioral: LEAD IT! Programming

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)	Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.	Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale	Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..	Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale	Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale	Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale	Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Month 1) and Treatment (Months 2, 3, and 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)	The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.	Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)	The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symptoms. The score ranges from 0 to 120. Lower scores represent a better outcome.	Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)	The GDS-SF consists of 15 questions requiring "yes" or "no" answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. The total score ranges from 0 to 15, with lower scores indicating a better outcome.	Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)	The 14-item CMAI is a caregiver rated questionnaire using a 5-point Likert scale to rate the frequency of disturbing behaviors in dementia such as verbal/physical aggression, general restlessness, strange noises, and so on. Scores range from 14 to 70, with lower scores indicating a better outcome.	Baseline (Month 1) and Post-Treatment (Month 4)

Collaborators and Investigators

• Sponsor: Hopeful Aging
• Investigators: Principal Investigator: Michael Skrajner, MA, Hearthstone

Study record dates

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 (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: psychosocial; social; non-pharmacological intervention
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Leukoencephalopathies; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Alzheimer Disease; Dementia; Dementia, Vascular
• 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