Toolkit for Experiential Well-beiNg in Dementia (TEND)

NCT ID: NCT06257563

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Dementia Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Isle of TEND Intervention

All participants will engage in the Isle of TEND Intervention.

Group Type EXPERIMENTAL

Isle of TEND Intervention

Intervention Type OTHER

The "Isle of TEND" is an interactive videogame platform in which users navigate to different modules on a virtual island. The modules aim to create a pleasant, shared and "error-free" experience for persons with dementia and their caregivers.

Interventions

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Isle of TEND Intervention

The "Isle of TEND" is an interactive videogame platform in which users navigate to different modules on a virtual island. The modules aim to create a pleasant, shared and "error-free" experience for persons with dementia and their caregivers.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christine S. Ritchie, MD, MPH

Director of Research, Division of Palliative Care and Geriatric Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Ritchie, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Ana-Maria Vranceanu

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Mass General Brigham

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 38157239 (View on PubMed)

Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. JAMA. 2010 Sep 1;304(9):983-91. doi: 10.1001/jama.2010.1253.

Reference Type BACKGROUND
PMID: 20810376 (View on PubMed)

Poon E. A Systematic Review and Meta-Analysis of Dyadic Psychological Interventions for BPSD, Quality of Life and/or Caregiver Burden in Dementia or MCI. Clin Gerontol. 2022 Jul-Sep;45(4):777-797. doi: 10.1080/07317115.2019.1694117. Epub 2019 Nov 22.

Reference Type BACKGROUND
PMID: 31752633 (View on PubMed)

Sorensen S, Duberstein P, Gill D, Pinquart M. Dementia care: mental health effects, intervention strategies, and clinical implications. Lancet Neurol. 2006 Nov;5(11):961-73. doi: 10.1016/S1474-4422(06)70599-3.

Reference Type BACKGROUND
PMID: 17052663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27193287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37115814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37361677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35877169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31247624 (View on PubMed)

Other Identifiers

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2022P001401

Identifier Type: -

Identifier Source: org_study_id

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