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

September 14, 2017 updated by: Linda Teri, University of Washington

From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
510

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 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
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.
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 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)
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.
Change from Baseline to Post-Treatment 2 (30 weeks)
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.
Change from Baseline to 13 Month Follow-Up
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.
Change from Baseline to 13 Month Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Revised Memory and Behavior Problem Checklist (RMBPC)
Time Frame: Baseline
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Baseline
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.
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)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Change from Baseline to 13 Month Follow-Up
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.
Baseline
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.
Change from Baseline to Pre-Treatment (6 weeks)
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.
Change from Baseline to Post-Treatment 1 (13 weeks)
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.
Change from Baseline to Post-Treatment 2 (30 weeks)
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.
Change from Baseline to 13 Month Follow-Up
CES-D
Time Frame: Baseline
This 20-item scale that assesses depression in caregivers.
Baseline
CES-D
Time Frame: Change from Baseline to Pre-Treatment (6 weeks)
A 20-item scale that assesses depression in caregivers.
Change from Baseline to Pre-Treatment (6 weeks)
CES-D
Time Frame: Change from Baseline to Post-Treatment 1 (13 weeks)
A 20-item scale that assesses depression in caregivers.
Change from Baseline to Post-Treatment 1 (13 weeks)
CES-D
Time Frame: Change from Baseline to Post-Treatment 2 (30 weeks)
A 20-item scale that assesses depression in caregivers.
Change from Baseline to Post-Treatment 2 (30 weeks)
CES-D
Time Frame: Change from Baseline to 13 Month Follow-Up
A 20-item scale that assesses depression in caregivers.
Change from Baseline to 13 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda Teri, Ph.D., University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 41906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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