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

NCT05516342 | Completed Results

• 1 other identifier: AG059443
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
3. 3.Examine the effects of resident-led LEAD IT! programming on RPs.
4. 4.Examine PWD and staff satisfaction with LEAD IT!

Conditions

Dementia, Vascular; Alzheimer Disease; Dementia, Mixed

Keywords

psychosocial; social; non-pharmacological intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)

  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)

  Baseline (Month 1) and Post-Treatment (Month 4)

• Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)

  Baseline (Month 1) and Post-Treatment (Month 4)

• Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)

  Baseline (Month 1) and Post-Treatment (Month 4)

Study Arms (2)

Experimental: Experimental, LEAD IT! Programming

EXPERIMENTAL

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

No Intervention: Control, Standard Care / Programming

NO INTERVENTION

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

Interventions

LEAD IT! Programming BEHAVIORAL

LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.

Experimental: Experimental, LEAD IT! Programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Must be at least 18 years old
• Must speak English
• n/a

Sponsors & Collaborators

• Hopeful Aging: lead

Study Sites (1)

The Hearthstone Institute, LLC

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Conditions

Dementia, Vascular; Alzheimer Disease; Mixed Dementias

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Michael Skrajner
• Organization: Hopeful Aging

mike@hopefulaging.com

4404777881

Study Officials

• Michael Skrajner, MA

  Hearthstone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 25, 2022
• Study Start: November 10, 2020
• Primary Completion: June 11, 2023
• Study Completion: June 11, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-05

Locations

US (1)