Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257563
Status:
WITHDRAWN
Last Update Posted:
2024-02-22
First Post:
2024-01-19
Brief Title:
Toolkit for Experiential Well-beiNg in Dementia TEND
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We are withdrawing our study due to regulatory requirements from our funding source
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEND
Brief Summary:
The goal of this project is to conduct an open pilot N5 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None