Clinical trial NCT05516147: SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia
Official title: SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Dementia, Vascular
Dementia, Mixed
Keywords: non-pharmacological intervention
psychosocial
Lead sponsor: Hopeful Aging
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the intervention
Primary purpose: TREATMENT

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.

Detailed description: Aim 1. Develop an Alpha version of the SAFE at Home app, including app infrastructure and preliminary activity content for live group sessions, as well as staff training and coaching modules. During Months 1-6, the Development Team (DT) will create the initial product design and prototype for use in the study. The study team will engage 5 PWD, 5 family members, and 5 activity professionals in focus groups to review the mockups and to understand end user preferences in terms of user experience and activity content. This will be the only involvement for these participants. New participants will be recruited for the quasi-experiment (described below). Aim 2. Examine the app's acceptability/feasibility (by assessing attendance, session length, and engagement/affect) During Months 5-10, the Experimental Team (ET) will utilize a quasi-experimental pre-post design (i.e., baseline vs. treatment / post-treatment) to conduct a two-month long acceptability and feasibility trial of SaH. During this trial 15 PWD, 15 Family Members, and 5 Life Enrichment professionals will use the product to determine functionality, acceptability, and feasibility. Baseline and Onboarding (Month 7). PWD: During the 4-week baseline period, the ET will collect the following data. PWD Demographics, medications, diagnoses, and type of dementia will be collected via proxy (family member) interview. The following assessments will be administered directly: the Short Portable Mental Status Questionnaire (SPMSQ-T), the Dementia Quality of Life Scale (DEMQOL), the Geriatric Depression Scale-Short Form (GDS-SF), and the UCLA Loneliness Scale (ULS). Researchers will interview family members (FMs) using the Neuropsychiatric Inventory-Nursing Home (NPI-NH). Using the Menorah Park Engagement Scale. researchers will observe PWD engagement and affect via videoconference on four days. This will allow us to determine "normal/baseline" engagement levels for each PWD and serve as a comparison for SaH. At the conclusion of the Baseline data collection, the ET will use the Get to Know You Portal with each PWD to determine their Cognitive and Communication levels as well as their interests. For the purposes of testing the feasibility of the SaH intervention, all group assignments will be made solely through the use of SaH tools. Staff Demographics will be collected. Staff will also take pre-training quizzes prior to taking the training modules. Family Members (FMs) will provide demographic information and serve as proxies for the above PWD measures. Intervention Period (Months 8-9). PWD: During the 8-week intervention period, PWD will participate in SaH sessions through the Social Engagement Portal. Sessions will occur twice per week and last 30-45 minutes. Staff: Staff will take the training modules developed in Aim 1 and will also run a simulated group and provide feedback. FMs will be involved simply by helping set up the hardware and helping their loved one with technical issues as needed (e.g., reconnecting to the videoconference if the connection is lost). Post Intervention Period (Month 10). PWD: The DEMQOL, GDS-SF, ULS, and NPI-NH will be re-administered at Post-Intervention, allowing us to investigate possible long-term effects. Changes on these longer-term measures are not expected in this Phase 1 study. However, data will be used to conduct power analyses for Phase 2. Staff: Staff will take post-training quizzes after completing the training modules. FMs will serve as proxies for some of the above measures. Milestones. This Aim will be considered successfully met if: (1) At least 85% of PWD agree to take part in 80% of the sessions. (2) Mean session length is least 25 minutes. (3) PWD exhibit higher levels of positive engagement/affect and lower levels of negative engagement during SaH sessions, as compared to baseline (based upon the MPES). This will be assessed by using paired samples t-tests. With the proposed sample, there will be a power of 99% to detect effects. A detailed power analysis is included in Clinical Trials-Statistical Design and Power. (4) Staff show an increase in knowledge after taking the training modules, based upon paired samples t-tests (pre-training quizzes vs. post-training quizzes). Aim 3. Examine satisfaction with the app by directly eliciting feedback from PWD and life enrichment staff. Overview: This Aim occurs concurrently with the Intervention Period for Aim 2 and utilizes the same sample and procedures-it merely tracks separate outcomes. Intervention Period (Months 8-9). PWD: During the intervention period, PWD will answer questions related to satisfaction at the end of each session. Staff: Staff will answer satisfaction questions related to the course and to the app (after the run a simulated group). FMs will answer satisfaction questions at the end of the study. Challenges. Since this aim occurs concurrently with Aim 2, no distinct challenges related solely to Aim 3 are expected. Milestones: This Aim will be considered successfully met if PWD, staff members, and FMs report high satisfaction with the app, defined as 85% being satisfied or very satisfied.

Eligibility criteria: PWD Inclusion Criteria:

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

PWD Exclusion Criteria:

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

Primary outcomes:
measure: Constructive Engagement Mean on Menorah Park Engagement Scale
timeFrame: Treatment (Weeks 5-10)
measure: Passive Engagement Mean on Menorah Park Engagement Scale
timeFrame: Treatment (Weeks 5-10)
measure: Other Engagement Mean on Menorah Park Engagement Scale
timeFrame: Treatment (Weeks 5-10)
measure: Non Engagement Mean on Menorah Park Engagement Scale
timeFrame: Treatment (Weeks 5-10)
measure: Pleasure Mean on Menorah Park Engagement Scale
timeFrame: Treatment (Weeks 5-10)
Secondary outcomes:
measure: Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the University of California, Los Angels (UCLA) Loneliness Scale
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Hopeful Aging
state: Massachusetts
Study officials:
affiliation: The Hearthstone Institute
name: Michael Skrajner, MA
role: PRINCIPAL_INVESTIGATOR
References: