Toolkit for Experiential Well-beiNg in Dementia (TEND)

Not Applicable

Withdrawn

• Conditions: Dementia; Alzheimer Disease
• Interventions: Other: Isle of TEND Intervention

• Registration Number: NCT06257563
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this project is to conduct an open pilot (N=5) among dyads (persons living with dementia and their caregivers) to assess the preliminary effects of an online videogame platform. The "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Dyads will use the platform three to four times a week for 20-30 minutes across four weeks. The investigators will assess for improvements in relationship satisfaction, wellbeing, and positive emotions and gather feedback on engagement in the platform. Dyads will complete measures at baseline and post-intervention as well as brief measures after each platform use.

Detailed Description

The aim of this phase is to assess initial active engagement, sustained attention, and positive emotions of the "Isle of TEND" intervention platform. Our participants (N = 5 dyads) will be persons living with moderate-severe dementia and their caregivers in the Boston area.

The intervention, "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Studio Elsewhere, a design and development team, developed the platform in consideration with feedback generated from focus groups and design workshops. Users navigate the online island and explore accompanying modules with varying audio and visual features. The platform aims to engage dyads in an enjoyable, shared, and "error-free" experience (i.e., creating poetry, viewing virtual art).

Participants will use their personal "travel journal" after each platform session, in which they log engagement and positive emotion. Dyads are also encouraged to provide free response feedback on the platform. Once a week, dyads will record themselves as they use the platform. The investigators will conclude the pilot with exit interviews. Baseline and post intervention assessments will include self-reported measures including relationship satisfaction, wellbeing, and caregiver stress. The research team will engage in behavioral observation coding to assess active engagement.

Study Timeline

• Study First Submitted: 2024-01-19
• Status Verified: 2024-02
• Study Start: 2024-02
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Informal caregiver (specifically, a family member) of a person with moderate-severe dementia and person with moderate-severe dementia
• Moderate to severe as determined by Functional Assessment Staging Tool (FAST Scale) taken by caregiver
• Age 18 or older
• English-speaking
• Willing and able to use the platform together 3-4 times a week for 20-30 minutes
• Located in the Boston area

Exclusion Criteria

• Lack of access to internet and/or a computer with a camera
• Untreated serious mental illness and or substance use diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isle of TEND Intervention	Isle of TEND Intervention	All participants will engage in the Isle of TEND Intervention.

Primary Outcome Measures

Name	Time	Method
Engagement	4 weeks	The investigators will examine whether the Isle of TEND is able to capture engagement among participants. Participants will complete the User Engagement Scale after each platform use to report engagement.; The User Engagement Scale is on a scale of 1 (Strongly disagree) to 5 (Strongly agree) with higher scores indicating greater engagement. Participants can score between 3 and 15.
Adherence	4 weeks	The investigators will measure adherence through objective and self report measures. Participants will log in a journal each time and duration they use the platform. Additionally, the website platform will run diagnostics to report aggregated use across all participants.

Secondary Outcome Measures

Name	Time	Method
Depression	4 weeks	The investigators will measure depression through the Geriatric Depression Scale. Participants will complete the Geriatric Depression Scale at baseline and post test periods.; The Geriatric Depression Scale (GRS) is on a Yes/No scale. A score greater than 5 indicates depression. Participants can score between 0 and 15.
Caregiver stress	4 weeks	The investigators will examine measure caregiver stress through the Modified Caregiver Stress Index. Participants will complete the MCSI at baseline and post test periods.; The Modified Caregiver Stress Index (MCSI) is on a scale of 2 (Yes, on a Regular Basis) to 0 (No). A higher score indicates greater caregiver stress. Participants can score between 0 and 26.
Relationship Satisfaction	4 weeks	The investigators will examine measure relationship satisfaction through the Dyadic Relationship Scale. Participants will complete the DRS at baseline and post test periods.; The Dyadic Relationship Scale (DRS) is on a scale of 0 (Strongly Agree) to 3 (Strongly Disagree). A higher score indicates greater relationship satisfaction. Participants can score between 0 and 33.

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States