- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
14 septembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
510
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98195
- University of Washington
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Minutes of exercise per week
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Délai: Baseline
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
|
Baseline
|
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
|
This 20-item scale that assesses depression in caregivers.
|
Baseline
|
|
CES-D
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Linda Teri, Ph.D., University of Washington
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2012
Achèvement primaire (Réel)
1 juin 2017
Achèvement de l'étude (Réel)
1 juin 2017
Dates d'inscription aux études
Première soumission
9 octobre 2012
Première soumission répondant aux critères de contrôle qualité
15 octobre 2012
Première publication (Estimation)
16 octobre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2017
Dernière vérification
1 septembre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 41906
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .