SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia

NCT05516147 | Completed Results

• 1 other identifier: R43AG075974
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed Phase 1 study will involve initial development and evaluation of a new service called Social Activities For Engagement at Home or SAFE at Home (SaH). SaH will enable PWD to participate in videoconference-based group activities with their peers-i.e., other PWD. SaH sessions will be facilitated by highly trained "Engagement Professionals," who will be SaH staff members that have a background in recreation therapy, activity coordination, or a similar field. The proposed study has three Specific Aims: Aim 1. Develop an Alpha version of the SaH app, including app infrastructure and preliminary activity content for live group sessions, as well as staff training and coaching modules. Aim 2. Examine the app's acceptability/feasibility (by assessing attendance, session length, and engagement/affect). Aim 3. Examine satisfaction with the app by directly eliciting feedback from PWD and life enrichment staff.

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular; Dementia, Mixed

Keywords

non-pharmacological intervention; psychosocial

Outcome Measures

Primary Outcomes (5)

• Constructive Engagement Mean on Menorah Park Engagement Scale

  Constructive Engagement on the Menorah Park Engagement Scale (MPES) is defined as doing or commenting on something related to the target activity. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.

  Treatment (Weeks 5-10)

• Passive Engagement Mean on Menorah Park Engagement Scale

  Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.

  Treatment (Weeks 5-10)

• Other Engagement Mean on 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. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.

  Treatment (Weeks 5-10)

• Non Engagement Mean on Menorah Park Engagement Scale

  Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Non Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.

  Treatment (Weeks 5-10)

• Pleasure Mean on Menorah Park Engagement Scale

  Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling.For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Non Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.28 for standard programming.

  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 University of California, Los Angels (UCLA) Loneliness Scale

  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)

Study Arms (1)

Treatment

EXPERIMENTAL

SAFE at Home Intervention

Behavioral: SAFE at Home

Interventions

SAFE at Home BEHAVIORAL

SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.

Treatment

Eligibility Criteria

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

You may qualify if:

• + years old
• speak and read conversational English
• diagnosed with dementia (any type)

You may not qualify if:

• signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.

Sponsors & Collaborators

• Hopeful Aging: lead

Study Sites (1)

Hopeful Aging

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular; Mixed Dementias

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; 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

440-477-7881

Study Officials

• Michael Skrajner, MA

  The Hearthstone Institute

  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 receive the intervention

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 25, 2022
• Study Start: January 19, 2024
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Locations

US (1)