Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

Completed · Not applicable

Conditions studied: Dementia

In brief

Alzheimer's 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 Alzheimer's 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.

Key facts

Study ID

NCT01550718

Run by

University of Washington

People needed

152

Starts

2012-02-01

Expected to finish

2015-02-01

Last updated by the study team

2015-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Dementia diagnosis
• Clinical Dementia Rating Scale score
• Care Partner agrees to participate with care recipient
• Care recipient lives in the community or a retirement home
• Both care partner and recipient speak English

You may not qualify if…

• Significant physical or psychiatric illness in either care partner or care recipient that would prevent participant in a exercise program
• Planning to move out of study area during the 4 month follow-up period

Where it is running

• UWashington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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