Toolkit for Experiential Well-beiNg in Dementia (TEND)

NCT06257563 | Withdrawn

• 1 other identifier: 2022P001401
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer Disease

Keywords

Bio-Experiential; Videogame; Psychosocial

Outcome Measures

Primary Outcomes (2)

• Engagement

  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.

  4 weeks

• Adherence

  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.

  4 weeks

Secondary Outcomes (3)

• Depression

  4 weeks

• Caregiver stress

  4 weeks

• Relationship Satisfaction

  4 weeks

Study Arms (1)

Isle of TEND Intervention

EXPERIMENTAL

All participants will engage in the Isle of TEND Intervention.

Other: Isle of TEND Intervention

Interventions

Isle of TEND Intervention 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.

Isle of TEND Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

Related Publications (9)

• 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.

  PMID: 38157239 BACKGROUND

• 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.

  PMID: 20810376 BACKGROUND

• 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.

  PMID: 31752633 BACKGROUND

• 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.

  PMID: 17052663 BACKGROUND

• 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.

  PMID: 27193287 BACKGROUND

• 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.

  PMID: 37115814 BACKGROUND

• 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.

  PMID: 37361677 BACKGROUND

• 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.

  PMID: 35877169 BACKGROUND

• 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.

  PMID: 31247624 BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Christine Ritchie, MD, MSPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Ana-Maria Vranceanu

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Division of Palliative Care and Geriatric Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 14, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)