- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00391794
Efficacy of Early Stage Alzheimer's Support Groups
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98115
- University of Washington
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: ESSG
eight weekly 90-minute sessions
|
8 week support group led by trained facilitators
Andra namn:
|
Aktiv komparator: ES
one 4-hour educational program
|
4 hour education session led by trained facilitators
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Quality of life
Tidsram: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Mood
Tidsram: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Social support
Tidsram: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Family Relationships
Tidsram: baseline, 3 months, and 6 months
|
baseline, 3 months, and 6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Rebecca G Logsdon, PhD., University of Washington
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 29920-J
- 5R01AG023091 (U.S.S. NIH-anslag/kontrakt)
- 06-1324-G01 (Annan identifierare: UW Human Subjects Division)
- 5R01AG023091-02 (U.S.S. NIH-anslag/kontrakt)
- 1A0131
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