- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391794
Efficacy of Early Stage Alzheimer's Support Groups
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With recent advances in diagnostic procedures and treatment options, many individuals with AD are now diagnosed early in the disease. Early diagnosis has many benefits: treatment can be started sooner, legal and financial planning can be addressed while the individual is able to participate in decision-making, and support services can be mobilized earlier. However, early diagnosis may also have negative consequences for the diagnosed individual's quality of life. Thus, diagnosis creates an obligation to help individuals and their families learn more about AD and cope with the impact of the diagnosis. Many Alzheimer's Association chapters have begun providing early stage support groups that focus on enhancing quality of life for participants and their caregivers. Anecdotal reports suggest that these groups improve quality of life of participants, but some individuals may also experience decreases in quality of life associated with stress, depression, or family conflict as a result of discussing current and future losses in the group. Thus, there is a need to systematically evaluate the benefits of these groups.
This study will evaluate and compare the efficacy of a structured, 8-session Early Stage Support Group intervention (ESSG) and a half-day Education Seminar (ES). Participants with early stage memory loss and their caregivers will be randomly assigned to either ESSG or ES. Both are presented by the Alzheimer's Association Western & Central Washington State Chapter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98115
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dementia diagnosis confirmed by primary care physician
- Early stage dementia, defined as a Mini Mental State Exam score of 18 or higher, and a Clinical Dementia Rating of 1 or less
- Care partner who will attend groups and complete study assessments
- Aware of memory loss (verbally acknowledges memory loss and/or expresses concern about memory)
- Comfortable in a group separate from family members
- No significant history of mental illness (no hospitalization or medication for psychotic disorder within the past 2 years)
- Consent to research participation (participant, care partner, legal representative)
- Remain in the community for the 6 month duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESSG
eight weekly 90-minute sessions
|
8 week support group led by trained facilitators
Other Names:
|
|
Active Comparator: ES
one 4-hour educational program
|
4 hour education session led by trained facilitators
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mood
Time Frame: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
|
Social support
Time Frame: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
|
Family Relationships
Time Frame: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca G Logsdon, PhD., University of Washington
Publications and helpful links
General Publications
- Quayhagen MP, Quayhagen M, Corbeil RR, Hendrix RC, Jackson JE, Snyder L, Bower D. Coping with dementia: evaluation of four nonpharmacologic interventions. Int Psychogeriatr. 2000 Jun;12(2):249-65. doi: 10.1017/s1041610200006360.
- Goldsilver PM, Gruneir MR. Early stage dementia group: an innovative model of support for individuals in the early stages of dementia. Am J Alzheimers Dis Other Demen. 2001 Mar-Apr;16(2):109-14. doi: 10.1177/153331750101600206.
- Snyder L, Quayhagen MP, Shepherd S, Bower D. Supportive seminar groups: an intervention for early stage dementia patients. Gerontologist. 1995 Oct;35(5):691-5. doi: 10.1093/geront/35.5.691.
- Zarit SH, Femia EE, Watson J, Rice-Oeschger L, Kakos B. Memory Club: a group intervention for people with early-stage dementia and their care partners. Gerontologist. 2004 Apr;44(2):262-9. doi: 10.1093/geront/44.2.262.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29920-J
- 5R01AG023091 (U.S. NIH Grant/Contract)
- 06-1324-G01 (Other Identifier: UW Human Subjects Division)
- 5R01AG023091-02 (U.S. NIH Grant/Contract)
- 1A0131
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