NCT00391794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

4.7 years

First QC Date

October 20, 2006

Last Update Submit

January 9, 2014

Conditions

Memory LossAlzheimer's DiseaseDementia

Keywords

MemoryAlzheimer's diseaseDementiaSupport GroupPsychosocial

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    baseline, 3 months, and 6 months

Secondary Outcomes (3)

  • Mood

    baseline, 3 months, and 6 months

  • Social support

    baseline, 3 months, and 6 months

  • Family Relationships

    baseline, 3 months, and 6 months

Study Arms (2)

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

Early Stage Memory Loss Support GroupBEHAVIORAL

8 week support group led by trained facilitators

Also known as: ESSG
ESSG
Educational SeminarBEHAVIORAL

4 hour education session led by trained facilitators

Also known as: ES
ES

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

Location

Related 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. doi: 10.1177/153331750101600206.

    PMID: 11302071BACKGROUND

  • 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.

    PMID: 10937544BACKGROUND

  • 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. doi: 10.1093/geront/35.5.691.

    PMID: 8543229BACKGROUND

  • 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. doi: 10.1093/geront/44.2.262.

    PMID: 15075423BACKGROUND

MeSH Terms

Conditions

Memory DisordersAlzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Rebecca G Logsdon, PhD.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)