Efficacy of Early Stage Alzheimer's Support Groups

January 9, 2014 updated by: Rebecca Logsdon, University of Washington
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.

Study Overview

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

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98115
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • ESSG
Active Comparator: ES
one 4-hour educational program
4 hour education session led by trained facilitators
Other Names:
  • ES

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rebecca G Logsdon, PhD., University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 23, 2006

First Posted (Estimate)

October 24, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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