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

Primary Purpose

Alzheimer's Disease, Dementia, Memory Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RDAD
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia, Alzheimer's Disease, Exercise, Caregiver, Behavior modification

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RDAD

Arm Description

Exercise training for caregiver and care recipient. Behavior modification training for caregiver.

Outcomes

Primary Outcome Measures

Minutes of exercise per week
Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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.
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.
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.
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.
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.
CES-D
This 20-item scale that assesses depression in caregivers.
CES-D
A 20-item scale that assesses depression in caregivers.
CES-D
A 20-item scale that assesses depression in caregivers.
CES-D
A 20-item scale that assesses depression in caregivers.
CES-D
A 20-item scale that assesses depression in caregivers.

Full Information

First Posted
October 9, 2012
Last Updated
September 14, 2017
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01708304
Brief Title
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)
Acronym
RDAD
Official Title
From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Memory Impairment, Cognitive Impairment
Keywords
Dementia, Alzheimer's Disease, Exercise, Caregiver, Behavior modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDAD
Arm Type
Other
Arm Description
Exercise training for caregiver and care recipient. Behavior modification training for caregiver.
Intervention Type
Behavioral
Intervention Name(s)
RDAD
Intervention Description
Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.
Primary Outcome Measure Information:
Title
Minutes of exercise per week
Description
Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
Time Frame
Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
Title
Restricted Activity Days
Description
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.
Time Frame
Baseline
Title
Restricted Activity Days
Description
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.
Time Frame
Change from Baseline to Pre-Treatment (6 weeks)
Title
Restricted Activity Days
Description
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.
Time Frame
Change from Baseline to Post- Treatment 1 (13 weeks)
Title
Restricted Activity Days
Description
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.
Time Frame
Change from Baseline to Post-Treatment 2 (30 weeks)
Title
Restricted Days of Activity
Description
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.
Time Frame
Change from Baseline to 13 Month Follow-Up
Title
Independence/Residential Status
Description
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.
Time Frame
Change from Baseline to 13 Month Follow-Up
Secondary Outcome Measure Information:
Title
Revised Memory and Behavior Problem Checklist (RMBPC)
Description
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Time Frame
Baseline
Title
Revised Memory and Behavior Problem Checklist (RMBPC)
Description
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Time Frame
Change from Baseline to Pre-Treatment (6 weeks)
Title
Revised Memory and Behavior Problem Checklist (RMBPC)
Description
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Time Frame
Change from Baseline to Post-Treatment 1 (13 weeks)
Title
Revised Memory and Behavior Problem Checklist (RMBPC)
Description
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Time Frame
Change from Baseline to Post-Treatment 2 (30 weeks)
Title
Revised Memory and Behavior Problem Checklist (RMBPC)
Description
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Time Frame
Change from Baseline to 13 Month Follow-Up
Title
Quality of Life-AD
Description
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.
Time Frame
Baseline
Title
Quality of Life-AD
Description
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.
Time Frame
Change from Baseline to Pre-Treatment (6 weeks)
Title
Quality of Life-AD
Description
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.
Time Frame
Change from Baseline to Post-Treatment 1 (13 weeks)
Title
Quality of Life-AD
Description
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.
Time Frame
Change from Baseline to Post-Treatment 2 (30 weeks)
Title
Quality of Life-AD
Description
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.
Time Frame
Change from Baseline to 13 Month Follow-Up
Title
CES-D
Description
This 20-item scale that assesses depression in caregivers.
Time Frame
Baseline
Title
CES-D
Description
A 20-item scale that assesses depression in caregivers.
Time Frame
Change from Baseline to Pre-Treatment (6 weeks)
Title
CES-D
Description
A 20-item scale that assesses depression in caregivers.
Time Frame
Change from Baseline to Post-Treatment 1 (13 weeks)
Title
CES-D
Description
A 20-item scale that assesses depression in caregivers.
Time Frame
Change from Baseline to Post-Treatment 2 (30 weeks)
Title
CES-D
Description
A 20-item scale that assesses depression in caregivers.
Time Frame
Change from Baseline to 13 Month Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Teri, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30304477
Citation
Teri L, Logsdon RG, McCurry SM, Pike KC, McGough EL. Translating an Evidence-based Multicomponent Intervention for Older Adults With Dementia and Caregivers. Gerontologist. 2020 Apr 2;60(3):548-557. doi: 10.1093/geront/gny122.
Results Reference
derived

Learn more about this trial

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

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