Clinical trial NCT06257563: Toolkit for Experiential Well-beiNg in Dementia (TEND)
Official title: Co-developing a Bio-experiential Approach and Intervention to Support the Mental Health and Well-being of Dementia Patients and Their Caregivers at Home (TEND)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: Bio-Experiential
Videogame
Psychosocial
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2024-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All dyads will use the "Isle of TEND" videogame platform for 20-30 minutes three-four times a week for four weeks. The Isle of TEND is supported on computers and laptops and is accessible through a link on any modern browser window.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Engagement
timeFrame: 4 weeks
measure: Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Depression
timeFrame: 4 weeks
measure: Caregiver stress
timeFrame: 4 weeks
measure: Relationship Satisfaction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christine Ritchie, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rochon EA, Sy M, Phillips M, Anderson E, Plys E, Ritchie C, Vranceanu AM. Bio-Experiential Technology to Support Persons With Dementia and Care Partners at Home (TEND): Protocol for an Intervention Development Study. JMIR Res Protoc. 2023 Dec 29;12:e52799. doi: 10.2196/52799.
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citation: Gilhooly KJ, Gilhooly ML, Sullivan MP, McIntyre A, Wilson L, Harding E, Woodbridge R, Crutch S. A meta-review of stress, coping and interventions in dementia and dementia caregiving. BMC Geriatr. 2016 May 18;16:106. doi: 10.1186/s12877-016-0280-8.
citation: Cheng Z, Zhou M, Sabran K. Mobile app-based interventions to improve the well-being of people with dementia: a systematic literature review. Assist Technol. 2024 Jan 2;36(1):64-74. doi: 10.1080/10400435.2023.2206439. Epub 2023 May 11.
citation: Cardona JS, Lopez JA, Vela FLG, Moreira F. Meaningful learning: motivations of older adults in serious games. Univers Access Inf Soc. 2023 Mar 14:1-16. doi: 10.1007/s10209-023-00987-y. Online ahead of print.
citation: Huang LC, Yang YH. The Long-term Effects of Immersive Virtual Reality Reminiscence in People With Dementia: Longitudinal Observational Study. JMIR Serious Games. 2022 Jul 25;10(3):e36720. doi: 10.2196/36720.
citation: Astell AJ, Bouranis N, Hoey J, Lindauer A, Mihailidis A, Nugent C, Robillard JM; Technology and Dementia Professional Interest Area .... Technology and Dementia: The Future is Now. Dement Geriatr Cogn Disord. 2019;47(3):131-139. doi: 10.1159/000497800. Epub 2019 Jun 27.