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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01708304
Other study ID # 41906
Secondary ID
Status Completed
Phase N/A
First received October 9, 2012
Last updated September 14, 2017
Start date November 2012
Est. completion date June 2017

Study information

Verified date September 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Behavioral:
RDAD
Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minutes of exercise per week 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
Primary Restricted Activity Days 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
Primary Restricted Activity Days 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)
Primary Restricted Activity Days 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)
Primary Restricted Activity Days 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)
Primary Restricted Days of Activity 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
Primary Independence/Residential Status 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
Secondary Revised Memory and Behavior Problem Checklist (RMBPC) Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction. Baseline
Secondary Revised Memory and Behavior Problem Checklist (RMBPC) Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction. Change from Baseline to Pre-Treatment (6 weeks)
Secondary Revised Memory and Behavior Problem Checklist (RMBPC) Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction. Change from Baseline to Post-Treatment 1 (13 weeks)
Secondary Revised Memory and Behavior Problem Checklist (RMBPC) Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction. Change from Baseline to Post-Treatment 2 (30 weeks)
Secondary Revised Memory and Behavior Problem Checklist (RMBPC) Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction. Change from Baseline to 13 Month Follow-Up
Secondary Quality of Life-AD 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
Secondary Quality of Life-AD 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)
Secondary Quality of Life-AD 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)
Secondary Quality of Life-AD 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)
Secondary Quality of Life-AD 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
Secondary CES-D This 20-item scale that assesses depression in caregivers. Baseline
Secondary CES-D A 20-item scale that assesses depression in caregivers. Change from Baseline to Pre-Treatment (6 weeks)
Secondary CES-D A 20-item scale that assesses depression in caregivers. Change from Baseline to Post-Treatment 1 (13 weeks)
Secondary CES-D A 20-item scale that assesses depression in caregivers. Change from Baseline to Post-Treatment 2 (30 weeks)
Secondary CES-D A 20-item scale that assesses depression in caregivers. Change from Baseline to 13 Month Follow-Up
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