Toolkit for Experiential Well-beiNg in Dementia (TEND) (TEND)

February 20, 2024 updated by: Christine S. Ritchie, MD, MPH, Massachusetts General Hospital

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Brigham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isle of TEND Intervention
All participants will engage in the Isle of TEND Intervention.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 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.
4 weeks
Engagement
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 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.
4 weeks
Caregiver stress
Time Frame: 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.
4 weeks
Relationship Satisfaction
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Christine Ritchie, MD, MSPH, Massachusetts General Hospital
  • Principal Investigator: Ana-Maria Vranceanu, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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