Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920591
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2021-06-02
Brief Title:
Doll Therapy in Dementia
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Efficacy of Doll thErapy Compared With Standard Treatment in the Control of Behavioral and Psychologic Symptoms and CaRegIver Burden of dEmentia
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESCRIBE
Brief Summary:
Behavioral and psychologic symptoms in dementia BPSD are frequent and represent a burden for patients and caregivers the use of a first line non-pharmacologic approach is highly recommended DESCRIBE is a randomized controlled trial on the effect of doll therapy DT on BPSD in different clinical settings
The investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and BPSD Subjects will be randomized to DT or standard treatment ST The investigators will measured agitation delirium and caregiver burden with standard clinical scales at baseline and during treatment Nursing home residents will be evaluated after 45 and 90 days of treatment in-patients will be evaluated at baseline and at hospital discharge In acute in-patients a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of DT withdrawal
Primary outcomes will be the reduction of BPSD and the reduction of professional caregiver burden Secondary outcome will be the reduction of delirium and of effect of family caregiver burden
The investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and BPSD Subjects will be randomized to DT or standard treatment ST The investigators will measured agitation delirium and caregiver burden with standard clinical scales at baseline and during treatment Nursing home residents will be evaluated after 45 and 90 days of treatment in-patients will be evaluated at baseline and at hospital discharge In acute in-patients a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of DT withdrawal
Primary outcomes will be the reduction of BPSD and the reduction of professional caregiver burden Secondary outcome will be the reduction of delirium and of effect of family caregiver burden
Detailed Description:
None
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