Overview

This trial is active, not recruiting.

Conditions alzheimer's disease, dementia, memory impairment, cognitive impairment
Treatment rdad
Sponsor University of Washington
Start date November 2012
End date February 2017
Trial size 510 participants
Trial identifier NCT01708304, 41906-D

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Exercise training for caregiver and care recipient. Behavior modification training for caregiver.
rdad
Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.

Primary Outcomes

Measure
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
Restricted Activity Days
time frame: Baseline
Restricted Activity Days
time frame: 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
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
Restricted Days of Activity
time frame: Change from Baseline to 13 Month Follow-Up
Independence/Residential Status
time frame: Change from Baseline to 13 Month Follow-Up

Secondary Outcomes

Measure
Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Baseline
Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: 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)
Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: 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
Quality of Life-AD
time frame: Baseline
Quality of Life-AD
time frame: Change from Baseline to Pre-Treatment (6 weeks)
Quality of Life-AD
time frame: Change from Baseline to Post-Treatment 1 (13 weeks)
Quality of Life-AD
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
Quality of Life-AD
time frame: Change from Baseline to 13 Month Follow-Up
CES-D
time frame: Baseline
CES-D
time frame: Change from Baseline to Pre-Treatment (6 weeks)
CES-D
time frame: Change from Baseline to Post-Treatment 1 (13 weeks)
CES-D
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
CES-D
time frame: Change from Baseline to 13 Month Follow-Up

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services
Principal investigator Linda Teri, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Washington.