- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00178568
Snížení stresu pečovatele a poruch spánku u pacientů s progresivní demencí
AgeWise Project 2: Snížení stresu a poruch spánku u pečovatelů o pacienty s progresivní demencí
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Obecným cílem této studie je charakterizovat poruchy spánku související se stresem u manželských pečovatelů o pacienty s progresivní demencí a otestovat účinnost intervence určené ke snížení stresu a poruch spánku. Porovnáme účinnost intervence Stress Management Plus Health Sleep Practices (SM+HSP) se stavem kontroly pouze pozornosti u manželských pečovatelů o pacienty s progresivní demencí.
Konkrétní cíle této studie jsou:
Cíl 1: Charakterizovat poruchy spánku související se stresem u manželských pečovatelů o pacienty s progresivní demencí.
Cíl 2: Otestovat krátkodobou účinnost intervence Stress Management Plus Healthy Sleep Practices (SM+HSP) oproti kontrole zaměřené pouze na pozornost pro zlepšení spánku a zdravotních výsledků u pečovatelů o pacienty s progresivní demencí.
Cíl 3: Otestovat trvanlivost intervence SM+HSP mezi manželskými pečovateli o pacienty s progresivní demencí.
Cíl 4: Charakterizovat:
- dopad poruch spánku souvisejících se stresem na zdraví starších dospělých a
- účinky spánkových intervencí na zdraví a fungování.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Kritéria pro zařazení:
- Věk 60 nebo starší
- Manželští pečovatelé pacientů s progresivní demencí
- Pacienti mají diagnózu možné nebo pravděpodobné Alzheimerovy choroby nebo jiné progresivní demence
- Potvrďte, že péče o manžela je fyzická a emocionální zátěž
- Pittsburgh Sleep Quality Index skóre 5 nebo vyšší nebo polysomnograficky stanovená účinnost spánku 90 % nebo horší.
Kritéria vyloučení:
- Psychotická porucha nebo porucha užívání návykových látek
- Index apnoe-hypopnoe vyšší než 30
- Skóre méně než 24 na mini-mentální státní zkoušce
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Polysomnografie před a po intervenci
Časové okno: 18 měsíců
|
sbírka fyziologických a psychologických proměnných před a po BBTI poruch spánku a stresu u pečovatelů
|
18 měsíců
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Martica Hall, Ph.D., University of Pittsburgh Medical Center
- Ředitel studie: Lynn Martire, Ph.D., University of Pittsburgh Medical Center
- Ředitel studie: Greg Seigel, Ph.D., University of Pittsburgh Medical Center
- Ředitel studie: Richard Schulz, Ph.D., University of Pittsburgh Medical Center
- Ředitel studie: Charles F. Reynolds, III, M.D., University of Pittsburgh Medical Center
Publikace a užitečné odkazy
Obecné publikace
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- Callan JA, Siegle GJ, Abebe K, Black B, Martire L, Schulz R, Reynolds C 3rd, Hall MH. Feasibility of a pocket-PC based cognitive control intervention in dementia spousal caregivers. Aging Ment Health. 2016;20(6):575-82. doi: 10.1080/13607863.2015.1031635. Epub 2015 May 6.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (AKTUÁLNÍ)
Dokončení studie (AKTUÁLNÍ)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (ODHAD)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (ODHAD)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 021117
- 1P01AG020677-01 (NIH)
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