- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00391794
Efficacy of Early Stage Alzheimer's Support Groups
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98115
- University of Washington
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ESSG
eight weekly 90-minute sessions
|
8 week support group led by trained facilitators
Andre navne:
|
|
Aktiv komparator: ES
one 4-hour educational program
|
4 hour education session led by trained facilitators
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Quality of life
Tidsramme: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mood
Tidsramme: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
|
Social support
Tidsramme: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
|
Family Relationships
Tidsramme: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rebecca G Logsdon, PhD., University of Washington
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 29920-J
- 5R01AG023091 (U.S. NIH-bevilling/kontrakt)
- 06-1324-G01 (Anden identifikator: UW Human Subjects Division)
- 5R01AG023091-02 (U.S. NIH-bevilling/kontrakt)
- 1A0131
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