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Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)

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ClinicalTrials.gov Identifier: NCT01708304
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Linda Teri, University of Washington

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Memory Impairment Cognitive Impairment Behavioral: RDAD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services
Study Start Date : November 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
RDAD
Exercise training for caregiver and care recipient. Behavior modification training for caregiver.
 Behavioral: RDAD
Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Baseline ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Quality of Life-AD [ Time Frame: 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. CES-D [ Time Frame: Baseline ]
    This 20-item scale that assesses depression in caregivers.

  12. CES-D [ Time Frame: Change from Baseline to Pre-Treatment (6 weeks) ]
    A 20-item scale that assesses depression in caregivers.

  13. CES-D [ Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks) ]
    A 20-item scale that assesses depression in caregivers.

  14. CES-D [ Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks) ]
    A 20-item scale that assesses depression in caregivers.

  15. CES-D [ Time Frame: Change from Baseline to 13 Month Follow-Up ]
    A 20-item scale that assesses depression in caregivers.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708304


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Linda Teri, Ph.D. University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Linda Teri, Professor, Psychosocial & Community Health, University of Washington
ClinicalTrials.gov Identifier: NCT01708304    
Other Study ID Numbers: 41906
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by Linda Teri, University of Washington:
Dementia
Alzheimer's Disease
Exercise
Caregiver
Behavior modification
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders