DementiaTENDNCT06257563
Toolkit for Experiential Well-beiNg in Dementia (TEND)
A study testing Isle of TEND Intervention in people with Dementia and Alzheimer Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Isle of TEND Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2024to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of access to internet and/or a computer with a camera
- Untreated serious mental illness and or substance use diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Isle of TEND Intervention
- Keywords
- Bio-Experiential, Videogame, Psychosocial
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isle of TEND InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isle of TEND Intervention | Experimental | All participants will engage in the Isle of TEND Intervention. Receives: Other: Isle of TEND Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
Depression
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.
Measured: 4 weeks
Caregiver stress
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.
Measured: 4 weeks
Relationship Satisfaction
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: We are withdrawing our study due to regulatory requirements from our funding source.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Christine S. Ritchie, MD, MPH, Massachusetts General Hospital
- Investigators
- Christine Ritchie, MD, MSPH, Principal investigator, Massachusetts General HospitalAna-Maria Vranceanu, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257563
- Sponsor's protocol ID
- 2022P001401
- Acronym
- TEND
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38157239Gitlin 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.
PubMed 20810376Poon 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.
PubMed 31752633Sorensen 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.
PubMed 17052663Gilhooly 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.
PubMed 27193287Cheng 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.
PubMed 37115814Cardona 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.
PubMed 37361677Huang 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.
PubMed 35877169Astell 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.
PubMed 31247624
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06257563
- Acronym / sponsor ID
- TEND / 2022P001401
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Bio-Experiential, Videogame, Psychosocial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are withdrawing our study due to regulatory requirements from our funding source.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isle of TEND Intervention | Experimental | Other: Isle of TEND InterventionAll participants will engage in the Isle of TEND Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of access to internet and/or a computer with a camera
- Untreated serious mental illness and or substance use diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isle of TEND InterventionThe "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. | Other | Isle of TEND Intervention |
Primary outcome
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.
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.
3 secondary outcomes
Depression
Time frame: 4 weeks
Caregiver stress
Time frame: 4 weeks
Relationship Satisfaction
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 38157239Rochon 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.
- Background: PubMed 20810376Gitlin 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.
- Background: PubMed 31752633Poon 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.
- Background: PubMed 17052663Sorensen 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.
- Background: PubMed 27193287Gilhooly 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.
- Background: PubMed 37115814Cheng 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.
- Background: PubMed 37361677Cardona 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.
- Background: PubMed 35877169Huang 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.
- Background: PubMed 31247624Astell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Ritchie, MD, MSPH principal investigator
Massachusetts General Hospital
Ana-Maria Vranceanu principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isle of TEND Intervention in people with Dementia and Alzheimer Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257563, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.