Efficacy of Early Stage Alzheimer's Support Groups | NCT00391794

Studies
Efficacy of Early Stage Alzheimer's Support Groups

NCT00391794

Sponsor

University of Washington

Status

Completed

Last Update Posted

Jan 10, 2014Estimated

Enrollment

154Actual

Phase

Not Applicable

Conditions

Memory Loss
Alzheimer's Disease
Dementia

Interventions

Early Stage Memory Loss Support Group
Educational Seminar

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01AG023091	U.S. NIH Grant/Contract		View source
06-1324-G01	Other Identifier	UW Human Subjects Division
5R01AG023091-02	U.S. NIH Grant/Contract		View source
1A0131

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 20, 2006

First Submission Date that Met QC Criteria

Oct 23, 2006

First Posted Date

Oct 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2014

Last Update Posted Date

Jan 10, 2014Estimated

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESSG	Experimental	eight weekly 90-minute sessions	Behavioral: Early Stage Memory Loss Support Group
ES	Active Comparator	one 4-hour educational program	Behavioral: Educational Seminar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early Stage Memory Loss Support Group	Behavioral	8 week support group led by trained facilitators	ESSG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life		baseline, 3 months, and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Mood		baseline, 3 months, and 6 months
Social support		baseline, 3 months, and 6 months
Family Relationships

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca G Logsdon, PhD.	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11302071	Background	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.
10937544	Background	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.

ID	Term
D008569	Memory Disorders
D000544	Alzheimer Disease
D003704	Dementia

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms