SAFE at Home for Dementia

Phase-Based Progress Estimates
The Hearthstone Institute, Winchester, MA
Dementia+3 More
SAFE at Home - Behavioral
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions

  • Dementia
  • Dementia, Vascular
  • Alzheimer Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Post-Treatment--that is week 13 thru week 14

Week 14
Dementia Related Quality of Life (DEMQOL)
Geriatric Depression Scale-Short Form (GDS-SF)
Neuropsychiatric Inventory-Nursing Home (NPI-NH)
UCLA Loneliness Scale (ULS)
Week 12
Menorah Park Engagement Scale (MPES)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

1 of 1
Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: SAFE at Home · No Placebo Group · N/A

Experimental Group · 1 Intervention: SAFE at Home · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-treatment--that is week 13 thru week 14
Closest Location: The Hearthstone Institute · Winchester, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Dementia
0 CompletedClinical Trials

Who is running the clinical trial?

The Hearthstone Institute, LLCLead Sponsor
3 Previous Clinical Trials
336 Total Patients Enrolled
3 Trials studying Dementia
336 Patients Enrolled for Dementia
Michael Skrajner, MAPrincipal InvestigatorThe Hearthstone Institute
3 Previous Clinical Trials
336 Total Patients Enrolled
3 Trials studying Dementia
336 Patients Enrolled for Dementia

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.