Ignite Creation Date:
2024-05-06 @ 12:21 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01550718
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2012-03-05
Brief Title:
Two Interventions for Early Stage Dementia A Comparative Efficacy Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Two Interventions for Early Stage Dementia A Comparative Efficacy Trial
Status:
COMPLETED
Status Verified Date:
2015-06
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:
None
Brief Summary:
Alzheimers disease AD is increasing exponentially with a projected quadrupling of cases by the mid 21st century Individuals with AD are at increased risk for a host of medical and psychiatric conditions and evidence is accumulating supporting the efficacy and effectiveness of psychosocial interventions for improving their mood function health and quality of life Such interventions are likely to be most effective when they are implemented during the early stages of dementia when individuals and their family members are coping with the initial diagnosis and associated changes in abilities and activities Recent randomized clinical trials by the Principal Investigator and colleagues have developed two non-pharmacologic interventions to reduce the social psychological physical and behavioral impact of dementia This investigation is focused on facilitating their translation into ongoing community-based programs such as those provided by Alzheimers Association chapters senior centers retirement homes and other health care providers The core content of each intervention has been retained in order to maintain or improve their efficacy and each has been modified to a 4-week group format to increase efficiency of delivery These modified interventions ESML-Social and ESML-Ex will be compared to each other and to a usual care UC control group Outcomes will be assessed at baseline 1-month post treatment and 4 month follow-up Primary outcomes at the 1-month assessment include social activity participation family communication physical activity participation and physical function Primary outcomes at 4-month follow up include overall quality of life and depression It is hypothesized that ESML-Ex and ESML-Social both will have greater improvements than UC It is hypothesized that ESML-Social will have greater improvements in social participation and family communication than ESML-Ex and UC It is hypothesized that ESML-Ex will have greater improvements in physical activity participation and physical functioning than ESML-Social and UC If successful these 4-week programs may be developed into modules that can be incorporated into programming for individuals with early stage dementia in a variety of community settings
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