- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
14 september 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
510
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98195
- University of Washington
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Minutes of exercise per week
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Tidsram: Baseline
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Baseline
|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
This 20-item scale that assesses depression in caregivers.
|
Baseline
|
|
CES-D
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Linda Teri, Ph.D., University of Washington
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2012
Primärt slutförande (Faktisk)
1 juni 2017
Avslutad studie (Faktisk)
1 juni 2017
Studieregistreringsdatum
Först inskickad
9 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
15 oktober 2012
Första postat (Uppskatta)
16 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2017
Senast verifierad
1 september 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 41906
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .