Alzheimer's DiseaseRDADNCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)
A study testing RDAD in people with Alzheimer's Disease and Dementia, run by University of Washington at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia, Memory Impairment
- What is being tested?
- RDAD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease, Dementia, Memory Impairment, Cognitive Impairment
- Being tested
- RDAD
- Keywords
- Dementia, Alzheimer's Disease, Exercise, Caregiver, Behavior modification
- Medical subject headings
- Alzheimer Disease, Dementia, Memory Disorders, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDADBehavioural
Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.
| Study group | Role | What they receive |
|---|---|---|
| RDAD | Other | Exercise training for caregiver and care recipient. Behavior modification training for caregiver. Receives: Behavioral: RDAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of exercise per week
Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
Measured: Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
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.
Measured: Baseline
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.
Measured: Change from Baseline to Pre-Treatment (6 weeks)
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.
Measured: Change from Baseline to Post- Treatment 1 (13 weeks)
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.
Measured: Change from Baseline to Post-Treatment 2 (30 weeks)
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.
Measured: Change from Baseline to 13 Month Follow-Up
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.
Measured: Change from Baseline to 13 Month Follow-Up
Secondary outcomes (15)
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Measured: Baseline
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Measured: Change from Baseline to Pre-Treatment (6 weeks)
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Measured: Change from Baseline to Post-Treatment 1 (13 weeks)
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Measured: Change from Baseline to Post-Treatment 2 (30 weeks)
Revised Memory and Behavior Problem Checklist (RMBPC)
Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
Measured: Change from Baseline to 13 Month Follow-Up
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.
Measured: Baseline
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.
Measured: Change from Baseline to Pre-Treatment (6 weeks)
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.
Measured: Change from Baseline to Post-Treatment 1 (13 weeks)
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.
Measured: Change from Baseline to Post-Treatment 2 (30 weeks)
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.
Measured: Change from Baseline to 13 Month Follow-Up
CES-D
This 20-item scale that assesses depression in caregivers.
Measured: Baseline
CES-D
A 20-item scale that assesses depression in caregivers.
Measured: Change from Baseline to Pre-Treatment (6 weeks)
CES-D
A 20-item scale that assesses depression in caregivers.
Measured: Change from Baseline to Post-Treatment 1 (13 weeks)
CES-D
A 20-item scale that assesses depression in caregivers.
Measured: Change from Baseline to Post-Treatment 2 (30 weeks)
CES-D
A 20-item scale that assesses depression in caregivers.
Measured: Change from Baseline to 13 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Teri, University of Washington
- Investigators
- Linda Teri, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708304
- Sponsor's protocol ID
- 41906
- Acronym
- RDAD
- Status last verified
- Sep 2017
- First submitted
- 9 Oct 2012
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30304477
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services
- ClinicalTrials.gov ID
- NCT01708304
- Acronym / sponsor ID
- RDAD / 41906
- Conditions
- Alzheimer's Disease, Dementia, Memory Impairment, Cognitive Impairment
- Keywords
- Dementia, Alzheimer's Disease, Exercise, Caregiver, Behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RDAD | Other | Behavioral: RDADExercise training for caregiver and care recipient. Behavior modification training for caregiver. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDADExercise training for caregiver and care recipient. Behavioral modification training for caregiver. | Behavioural | RDAD |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
15 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 30304477Teri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Teri, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDAD in people with Alzheimer's Disease and Dementia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.