- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
14. září 2017 aktualizováno: Linda Teri, University of Washington
From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services
The University of Washington's Northwest Research Group on Aging is partnering with Area Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation of RDAD (Reducing Disabilities in Alzheimer's Disease).
RDAD is an evidence-based program with demonstrated efficacy in helping older adults with dementia maintain physical function and remain physically and mentally healthy.
This study asks two questions: 1) Can AAA partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD effective in producing desired outcomes among agencies, providers, and older adults with dementia and their family members.
This study is being conducted in Washington and Oregon states.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
510
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Washington
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Seattle, Washington, Spojené státy, 98195
- University of Washington
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
65 let a starší (Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
Care Recipients must
- Have a diagnosis of dementia
- Be 65 years of age or older
- Currently exercise no more than 150 minutes a week and not regularly participate in a formal exercise program.
Caregivers must
- Live in the community
- Provide care to the care recipient with dementia
Exclusion Criteria:
Either Care-recipient or Caregiver must not
- Plan to move to a long-term residential care setting within 6 months of enrollment.
- Plan to move from the study geographic area within 4 months of enrollment.
- Have a known terminal illness (with death anticipated within the next 12 months)
- Have had a hospitalization for a psychiatric disorder in the 12 months prior to baseline
- Be actively suicidal, hallucinating, or delusional
- Be blind, deaf, or not ambulatory
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Jiný: RDAD
Exercise training for caregiver and care recipient.
Behavior modification training for caregiver.
|
Exercise training for caregiver and care recipient.
Behavioral modification training for caregiver.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Minutes of exercise per week
Časové okno: Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
|
Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
|
Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
|
Restricted Activity Days
Časové okno: Baseline
|
Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
|
Baseline
|
Restricted Activity Days
Časové okno: Change from Baseline to Pre-Treatment (6 weeks)
|
Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
|
Change from Baseline to Pre-Treatment (6 weeks)
|
Restricted Activity Days
Časové okno: Change from Baseline to Post- Treatment 1 (13 weeks)
|
Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
|
Change from Baseline to Post- Treatment 1 (13 weeks)
|
Restricted Activity Days
Časové okno: Change from Baseline to Post-Treatment 2 (30 weeks)
|
Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
|
Change from Baseline to Post-Treatment 2 (30 weeks)
|
Restricted Days of Activity
Časové okno: Change from Baseline to 13 Month Follow-Up
|
Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
|
Change from Baseline to 13 Month Follow-Up
|
Independence/Residential Status
Časové okno: Change from Baseline to 13 Month Follow-Up
|
All participants will be in independent living situations at baseline.
Any move from independent living to a care facility will be documented throughout the 13 month study.
|
Change from Baseline to 13 Month Follow-Up
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Revised Memory and Behavior Problem Checklist (RMBPC)
Časové okno: Baseline
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Baseline
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Časové okno: Change from Baseline to Pre-Treatment (6 weeks)
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Change from Baseline to Pre-Treatment (6 weeks)
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Časové okno: Change from Baseline to Post-Treatment 1 (13 weeks)
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Change from Baseline to Post-Treatment 1 (13 weeks)
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Časové okno: Change from Baseline to Post-Treatment 2 (30 weeks)
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Change from Baseline to Post-Treatment 2 (30 weeks)
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Časové okno: Change from Baseline to 13 Month Follow-Up
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Change from Baseline to 13 Month Follow-Up
|
Quality of Life-AD
Časové okno: Baseline
|
This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
|
Baseline
|
Quality of Life-AD
Časové okno: Change from Baseline to Pre-Treatment (6 weeks)
|
This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
|
Change from Baseline to Pre-Treatment (6 weeks)
|
Quality of Life-AD
Časové okno: Change from Baseline to Post-Treatment 1 (13 weeks)
|
This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
|
Change from Baseline to Post-Treatment 1 (13 weeks)
|
Quality of Life-AD
Časové okno: Change from Baseline to Post-Treatment 2 (30 weeks)
|
This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
|
Change from Baseline to Post-Treatment 2 (30 weeks)
|
Quality of Life-AD
Časové okno: Change from Baseline to 13 Month Follow-Up
|
This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
|
Change from Baseline to 13 Month Follow-Up
|
CES-D
Časové okno: Baseline
|
This 20-item scale that assesses depression in caregivers.
|
Baseline
|
CES-D
Časové okno: Change from Baseline to Pre-Treatment (6 weeks)
|
A 20-item scale that assesses depression in caregivers.
|
Change from Baseline to Pre-Treatment (6 weeks)
|
CES-D
Časové okno: Change from Baseline to Post-Treatment 1 (13 weeks)
|
A 20-item scale that assesses depression in caregivers.
|
Change from Baseline to Post-Treatment 1 (13 weeks)
|
CES-D
Časové okno: Change from Baseline to Post-Treatment 2 (30 weeks)
|
A 20-item scale that assesses depression in caregivers.
|
Change from Baseline to Post-Treatment 2 (30 weeks)
|
CES-D
Časové okno: Change from Baseline to 13 Month Follow-Up
|
A 20-item scale that assesses depression in caregivers.
|
Change from Baseline to 13 Month Follow-Up
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Linda Teri, Ph.D., University of Washington
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2012
Primární dokončení (Aktuální)
1. června 2017
Dokončení studie (Aktuální)
1. června 2017
Termíny zápisu do studia
První předloženo
9. října 2012
První předloženo, které splnilo kritéria kontroly kvality
15. října 2012
První zveřejněno (Odhad)
16. října 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. září 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. září 2017
Naposledy ověřeno
1. září 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 41906
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na RDAD
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University of WashingtonNational Institute on Aging (NIA)DokončenoDemence | Alzheimerova nemoc | Mírná kognitivní porucha | Vaskulární demence | Demence s Lewyho tělem | Parkinsonova nemoc DemenceSpojené státy