Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597981
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Testing of a Dyadic Empowerment-based Sport Stacking Program to Improve Health Outcomes of People with Mild Dementia and Their Family Caregivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to develop and test a dyadic empowerment-based sport stacking program to improve health outcomes of people with mild dementia and their family caregivers
The research hypotheses to be tested are
i People with dementia who receive the dyadic empowerment-based sport stacking program will report a greater improvement in cognitive function a greater reduction in cognitive and neuropsychiatric symptoms a greater reduction in depressive symptoms and a greater improvement in health-related quality of life HRQOL at T1 12th week and T2 18th week compared to the usual care group ii Caregivers who receive the dyadic empowerment-based sport stacking program will report less stressful in managing the cognitive and neuropsychiatric symptoms a greater reduction in depressive symptoms and a greater improvement in HRQOL at T1 12th week and T2 18th week compared to the usual care group iii The care dyads who receive the dyadic empowerment-based sport stacking program will report less dyadic relationship strain at T1 12th week and T2 18th week compared to the usual care group
For the intervention group the care dyads will receive an 18-week dyadic empowerment-based sport stacking program which is divided into two phases the active phase weeks 1-12 and the maintenance phase weeks 13-18 In the active phase the care dyads will engage in three online sessions in small groups 3-5 dyadsgroup and three check-upsupport sessions Three online sessions will be scheduled at weeks 1 3 and 9 during the 12-week active phase They will also be required to engage in self-practice at home for at least 30 minutes per day five times per week during this time according to their training schedule In the maintenance phase there will be three online sessions in small groups 3-5 dyadsgroup Three online sessions will be scheduled at weeks 13 16 and 18 The dyads will continue their self-practice at home at least 30 minutesday five timesweek for 6 weeks
Participants in the control group will receive basic education on dementia caregiving which will comprise three group-based 3-5 dyadsgroup online meetings in the same schedule as the intervention group 1st 3rd 9th week
The research hypotheses to be tested are
i People with dementia who receive the dyadic empowerment-based sport stacking program will report a greater improvement in cognitive function a greater reduction in cognitive and neuropsychiatric symptoms a greater reduction in depressive symptoms and a greater improvement in health-related quality of life HRQOL at T1 12th week and T2 18th week compared to the usual care group ii Caregivers who receive the dyadic empowerment-based sport stacking program will report less stressful in managing the cognitive and neuropsychiatric symptoms a greater reduction in depressive symptoms and a greater improvement in HRQOL at T1 12th week and T2 18th week compared to the usual care group iii The care dyads who receive the dyadic empowerment-based sport stacking program will report less dyadic relationship strain at T1 12th week and T2 18th week compared to the usual care group
For the intervention group the care dyads will receive an 18-week dyadic empowerment-based sport stacking program which is divided into two phases the active phase weeks 1-12 and the maintenance phase weeks 13-18 In the active phase the care dyads will engage in three online sessions in small groups 3-5 dyadsgroup and three check-upsupport sessions Three online sessions will be scheduled at weeks 1 3 and 9 during the 12-week active phase They will also be required to engage in self-practice at home for at least 30 minutes per day five times per week during this time according to their training schedule In the maintenance phase there will be three online sessions in small groups 3-5 dyadsgroup Three online sessions will be scheduled at weeks 13 16 and 18 The dyads will continue their self-practice at home at least 30 minutesday five timesweek for 6 weeks
Participants in the control group will receive basic education on dementia caregiving which will comprise three group-based 3-5 dyadsgroup online meetings in the same schedule as the intervention group 1st 3rd 9th week
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None