Efficacy of Early Stage Alzheimer's Support Groups

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rebecca Logsdon, University of Washington
ClinicalTrials.gov Identifier:
NCT00391794
First received: October 20, 2006
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention
Memory Loss
Alzheimer's Disease
Dementia
Behavioral: Early Stage Memory Loss Support Group
Behavioral: Educational Seminar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Early Stage Alzheimer's Support Groups

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Quality of life [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Family Relationships [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: September 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391794

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Rebecca G Logsdon, PhD. University of Washington
  More Information

Publications:
Responsible Party: Rebecca Logsdon, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00391794     History of Changes
Other Study ID Numbers: 29920-J, 5R01AG023091, 06-1324-G01, 5R01AG023091-02, 1A0131
Study First Received: October 20, 2006
Last Updated: January 9, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Memory
Alzheimer's disease
Dementia
Support Group
Psychosocial

Additional relevant MeSH terms:
Alzheimer Disease
Amnesia
Memory Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014