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Efficacy of Early Stage Alzheimer's Support Groups

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00391794
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : January 10, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Rebecca Logsdon, University of Washington

Brief Summary:
The purpose of this study is to evaluate the impact of an Early Stage Memory Loss Support Group (ESSG) and Education Seminar (ES) on quality of life, mood, social support, distress about memory loss, and interpersonal relationships of memory loss participants and their caregivers.

Condition or disease Intervention/treatment Phase
Memory Loss Alzheimer's Disease Dementia Behavioral: Early Stage Memory Loss Support Group Behavioral: Educational Seminar Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Early Stage Alzheimer's Support Groups
Study Start Date : September 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: ESSG
eight weekly 90-minute sessions
Behavioral: Early Stage Memory Loss Support Group
8 week support group led by trained facilitators
Other Name: ESSG

Active Comparator: ES
one 4-hour educational program
Behavioral: Educational Seminar
4 hour education session led by trained facilitators
Other Name: ES




Primary Outcome Measures :
  1. Quality of life [ Time Frame: baseline, 3 months, and 6 months ]

Secondary Outcome Measures :
  1. Mood [ Time Frame: baseline, 3 months, and 6 months ]
  2. Social support [ Time Frame: baseline, 3 months, and 6 months ]
  3. Family Relationships [ Time Frame: baseline, 3 months, and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391794


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Rebecca G Logsdon, PhD. University of Washington
Publications:
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Responsible Party: Rebecca Logsdon, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00391794    
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
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Rebecca Logsdon, University of Washington:
Memory
Alzheimer's disease
Dementia
Support Group
Psychosocial
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations