Efficacy of Early Stage Alzheimer's Support Groups

Dementia Clinical Trial

Official title:

Efficacy of Early Stage Alzheimer's Support Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391794
• Other study ID #: 29920-J
• Secondary ID: 5R01AG02309106-1
• Status: Completed
• Phase: N/A
• First received: October 20, 2006
• Last updated: January 9, 2014
• Start date: September 2006
• Est. completion date: May 2011

Study information

• Verified date: January 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Memory Loss

Intervention

Behavioral:
• Early Stage Memory Loss Support Group
8 week support group led by trained facilitators
• Educational Seminar
4 hour education session led by trained facilitators

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		baseline, 3 months, and 6 months	No
Secondary	Mood		baseline, 3 months, and 6 months	No
Secondary	Social support		baseline, 3 months, and 6 months	No
Secondary	Family Relationships		baseline, 3 months, and 6 months	No