- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
September 14, 2017 updated by: 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
510
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: RDAD
Exercise training for caregiver and care recipient.
Behavior modification training for caregiver.
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Exercise training for caregiver and care recipient.
Behavioral modification training for caregiver.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minutes of exercise per week
Time Frame: 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.
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Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
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Restricted Activity Days
Time Frame: 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.
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Baseline
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Restricted Activity Days
Time Frame: 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
Time Frame: 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)
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Restricted Activity Days
Time Frame: 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)
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Restricted Days of Activity
Time Frame: 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
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Independence/Residential Status
Time Frame: 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.
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Change from Baseline to 13 Month Follow-Up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Memory and Behavior Problem Checklist (RMBPC)
Time Frame: Baseline
|
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Baseline
|
Revised Memory and Behavior Problem Checklist (RMBPC)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: Baseline
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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.
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Baseline
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Quality of Life-AD
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
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This 20-item scale that assesses depression in caregivers.
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Baseline
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CES-D
Time Frame: Change from Baseline to Pre-Treatment (6 weeks)
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A 20-item scale that assesses depression in caregivers.
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Change from Baseline to Pre-Treatment (6 weeks)
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CES-D
Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks)
|
A 20-item scale that assesses depression in caregivers.
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Change from Baseline to Post-Treatment 1 (13 weeks)
|
CES-D
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linda Teri, Ph.D., University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 9, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41906
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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