Clinical trial NCT01550718: Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial
Official title: Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Aerobic Exercise
Alzheimer's Disease
Burden and Stress
Caregiving Issues
Quality of Life
Early Stage Memory Loss
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Social Activity at post-treatment (1 month)
timeFrame: Baseline and post treatment (1 month)
measure: Change from Baseline in Physical Activity at post-treatment (1 month)
timeFrame: Baseline and post-treatment (1 month)
measure: Change from Baseline in Quality of Life at post-treatment (1 month)
timeFrame: Baseline and post treatment (1 month)
measure: Change from Baseline in Social Activity at 4 month follow-up
timeFrame: Baseline and 4 month follow-up
measure: Change from Baseline in Physical Activity at 4 month follow-up
timeFrame: Baseline and 4 month follow-up
measure: Change from Baseline in Quality of Life at 4 month follow-up
timeFrame: Baseline and 4 month follow-up
Secondary outcomes:
measure: Change from Baseline in Communication at post-treatment (1 month)
timeFrame: Baseline and post treatment (1 month)
measure: Change from Baseline in Physical Function at post-treatment (1 month)
timeFrame: Baseline and post treatment (1 month)
measure: Change from Baseline in Mood at post-treatment (1 month)
timeFrame: Baseline and post-treatment (1 month)
measure: Change from Baseline in Communication at post-treatment (1 month)
timeFrame: Baseline and post-treatment (1 month)
measure: Change from Baseline in Physical Functioning at post-treatment (1 month)
timeFrame: Baseline and post-treatment (1 month)
measure: Change from Baseline in Mood at 4 month follow-up.
timeFrame: Baseline and 4 month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UWashington
state: Washington
Study officials:
affiliation: University of Washington
name: Rebecca G Logsdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: