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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Linda Teri, University of Washington
ClinicalTrials.gov Identifier:
NCT01708304
First received: October 9, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Alzheimer's Disease
Dementia
Memory Impairment
Cognitive Impairment
Behavioral: RDAD

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.

  • Restricted Activity Days [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Restricted Activity Days [ Time Frame: Change from Baseline to Pre-Treatment (6 weeks) ] [ Designated as safety issue: No ]
    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.

  • Restricted Activity Days [ Time Frame: Change from Baseline to Post- Treatment 1 (13 weeks) ] [ Designated as safety issue: No ]
    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.

  • Restricted Activity Days [ Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks) ] [ Designated as safety issue: No ]
    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.

  • Restricted Days of Activity [ Time Frame: Change from Baseline to 13 Month Follow-Up ] [ Designated as safety issue: No ]
    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.

  • Independence/Residential Status [ Time Frame: Change from Baseline to 13 Month Follow-Up ] [ Designated as safety issue: No ]
    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:
  • Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  • Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Change from Baseline to Pre-Treatment (6 weeks) ] [ Designated as safety issue: No ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  • Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks) ] [ Designated as safety issue: No ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  • Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks) ] [ Designated as safety issue: No ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  • Revised Memory and Behavior Problem Checklist (RMBPC) [ Time Frame: Change from Baseline to 13 Month Follow-Up ] [ Designated as safety issue: No ]
    Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.

  • Quality of Life-AD [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Quality of Life-AD [ Time Frame: Change from Baseline to Pre-Treatment (6 weeks) ] [ Designated as safety issue: No ]
    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.

  • Quality of Life-AD [ Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks) ] [ Designated as safety issue: No ]
    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.

  • Quality of Life-AD [ Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks) ] [ Designated as safety issue: No ]
    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.

  • Quality of Life-AD [ Time Frame: Change from Baseline to 13 Month Follow-Up ] [ Designated as safety issue: No ]
    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.

  • CES-D [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This 20-item scale that assesses depression in caregivers.

  • CES-D [ Time Frame: Change from Baseline to Pre-Treatment (6 weeks) ] [ Designated as safety issue: No ]
    A 20-item scale that assesses depression in caregivers.

  • CES-D [ Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks) ] [ Designated as safety issue: No ]
    A 20-item scale that assesses depression in caregivers.

  • CES-D [ Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks) ] [ Designated as safety issue: No ]
    A 20-item scale that assesses depression in caregivers.

  • CES-D [ Time Frame: Change from Baseline to 13 Month Follow-Up ] [ Designated as safety issue: No ]
    A 20-item scale that assesses depression in caregivers.


Estimated Enrollment: 416
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708304

Contacts
Contact: Amy L Moore Cunningham, M.S. 206-616-5550 amoore@u.washington.edu
Contact: June van Leynseele, M.A. 206-221-3857 juneva@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Amy Moore Cunningham, MS    206-616-5550    amoore@u.washington.edu   
Principal Investigator: Linda Teri, Ph.D.         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Linda Teri, Ph.D. University of Washington
  More Information

No publications provided

Responsible Party: Linda Teri, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01708304     History of Changes
Other Study ID Numbers: 41906-K
Study First Received: October 9, 2012
Last Updated: December 9, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Dementia
Alzheimer's Disease
Exercise
Caregiver
Behavior modification

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Memory Disorders
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014