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NCT01550718 · ClinicalTrials.gov registry record · NA
Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
NCT01550718 is a NA study that has completed, run by University of Washington. The registered enrollment target is 152 participants.
The verdict
NCT01550718, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
Study 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 improv
Interventions
- BEHAVIORAL ESML-EX (Physical Activity Program)
- BEHAVIORAL ESML-Social (Social Activity Program)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01550718
The ClinicalTrials.gov registry entry for NCT01550718 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ESML-EX (Physical Activity Program) is the first listed.
NCT01550718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01550718 about?
NCT01550718 is a clinical study titled "Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial". 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 inte...
What is the current status of trial NCT01550718?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2012-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01550718?
The interventions under investigation include: ESML-EX (Physical Activity Program) (BEHAVIORAL), ESML-Social (Social Activity Program) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01550718?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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