All About Me: An Intervention to Ease the Transition to Long Term Care

NCT05516134 | Completed Results

• 1 other identifier: AG077993-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I study will involve initial development and evaluation of an innovative cross-platform software app called All About Me (AAM), which will consist of Serious Digital Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care and enable residents to improve relationships with one another and with staff, thereby promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App, and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on engagement/affect.

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Dementia, Mixed; Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (5)

• Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale

  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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

• 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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

  Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

• 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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

• 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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

• 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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

  Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Secondary Outcomes (4)

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

  Baseline (Weeks 1-4) and Post-Treatment (Week 11)

• Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)

  Baseline (Weeks 1-4) and Post-Treatment (Week 11)

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

  Baseline (Weeks 1-4) and Post-Treatment (Week 11)

• Satisfaction With the App

  Treatment (Weeks 5-11)

Study Arms (1)

Treatment

EXPERIMENTAL

Participants who receive the intervention (all)

Behavioral: SAFE at Home

Interventions

SAFE at Home BEHAVIORAL

The All About Me (AAM) app will consist of Serious Digital Health Games for PWD. The market-ready version of the app will consist of five components. (1) The Fun Facts About Me Game will be used when a PWD is moving into LTC. The goal of the game is to provide an enjoyable way for family members and PWD to provide important information about the PWD's background. (2) The Resident Game Bundle will consist of SDHGs that will allow PWD to learn about one another in an enjoyable way. (3) The My Residents Module will provide staff with a convenient way to view information about a PWD with whom they will be working. Staff will launch this module from any device. (4) The Meet the Staff Module, which will be developed and tested in a future Phase II study, will allow residents to learn about staff members at their community. (5) The AAM Training Modules will provide staff and family members with access to video-based training modules that describe how to use relevant portions of the app

Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be 60+ years old
• must speak and read English
• must have a clinical diagnosis of dementia (of any type)
• must score at least eight on the Mini-Mental Status Examination (MMSE)

You may not qualify if:

• shows signs of rapid physical / cognitive decline over the past six months, as indicated by medical records

Sponsors & Collaborators

• Hopeful Aging: lead

Study Sites (1)

Hopeful Aging

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Mixed Dementias

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael Skrajner
• Organization: Hopeful Aging

mike@hopefulaging.com

4404777881

Study Officials

• Michael Skrajner, MA

  Hopeful Aging

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: All participants will receive the intervention

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 25, 2022
• Study Start: April 18, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Locations

US (1)