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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alzheimer Disease, Dementia, Dementia, Vascular, Dementia, Mixed

Intervention / Treatment
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* Behavioral: SAFE at Home


Participation Criteria
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Eligibility Criteria
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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. Staff and Family Member Inclusion Criteria 18+ years old speak and read conversational English Staff and Family Member Exclusion Criteria -n/a

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>SAFE at Home Intervention | Behavioral: SAFE at Home<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menorah Park Engagement Scale (MPES) | The MPES is an observational scale that measures four types of engagement, including Constructive Engagement, Passive Engagement, Other Engagement, and Non Engagement. The MPES also measures pleasure. | Baseline--that is, week 1 thru week 4 | 
| Menorah Park Engagement Scale (MPES) | The MPES is an observational scale that measures four types of engagement, including Constructive Engagement, Passive Engagement, Other Engagement, and Non Engagement. The MPES also measures pleasure. | Treatment--that is, week 5 thru week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia Related Quality of Life (DEMQOL) | The DEMQOL measures quality of life for persons with dementia and is composed of 28 items. It also has a proxy version. | Baseline--that is, week 1 thru week 4 | 
| Dementia Related Quality of Life (DEMQOL) | The DEMQOL measures quality of life for persons with dementia and is composed of 28 items. It also has a proxy version. | Post-Treatment--that is week 13 thru week 14 | 
| Geriatric Depression Scale-Short Form (GDS-SF) | The GDS-SF consists of 15 questions requiring yes or no answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. | Baseline--that is, week 1 thru week 4 | 
| Geriatric Depression Scale-Short Form (GDS-SF) | The GDS-SF consists of 15 questions requiring yes or no answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. | Post-Treatment--that is week 13 thru week 14 | 
| Neuropsychiatric Inventory-Nursing Home (NPI-NH) | The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency | Baseline--that is, week 1 thru week 4 | 
| Neuropsychiatric Inventory-Nursing Home (NPI-NH) | The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency | Post-Treatment--that is week 13 thru week 14 | 
| UCLA Loneliness Scale (ULS) | This scale measures one's subjective feelings of loneliness as well as feelings of social isolation. | Baseline--that is, week 1 thru week 4 | 
| UCLA Loneliness Scale (ULS) | This scale measures one's subjective feelings of loneliness as well as feelings of social isolation. | Post-Treatment--that is week 13 thru week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-pharmacological intervention, psychosocial