- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
14. september 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
510
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98195
- University of Washington
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Minutes of exercise per week
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Tidsramme: Baseline
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Baseline
|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
This 20-item scale that assesses depression in caregivers.
|
Baseline
|
|
CES-D
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Linda Teri, Ph.D., University of Washington
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2012
Primær fullføring (Faktiske)
1. juni 2017
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
9. oktober 2012
Først innsendt som oppfylte QC-kriteriene
15. oktober 2012
Først lagt ut (Anslag)
16. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2017
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 41906
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