NCT01708304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

4.6 years

First QC Date

October 9, 2012

Last Update Submit

September 14, 2017

Conditions

Keywords

DementiaAlzheimer's DiseaseExerciseCaregiverBehavior modification

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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)

  • 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)

  • 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)

  • 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

  • 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 Outcomes (15)

  • Revised Memory and Behavior Problem Checklist (RMBPC)

    Baseline

  • Revised Memory and Behavior Problem Checklist (RMBPC)

    Change from Baseline to Pre-Treatment (6 weeks)

  • Revised Memory and Behavior Problem Checklist (RMBPC)

    Change from Baseline to Post-Treatment 1 (13 weeks)

  • Revised Memory and Behavior Problem Checklist (RMBPC)

    Change from Baseline to Post-Treatment 2 (30 weeks)

  • Revised Memory and Behavior Problem Checklist (RMBPC)

    Change from Baseline to 13 Month Follow-Up

  • +10 more secondary outcomes

Study Arms (1)

RDAD

OTHER

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

Behavioral: RDAD

Interventions

RDADBEHAVIORAL

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

RDAD

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMemory DisordersCognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersBehavior

Study Officials

  • Linda Teri, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychosocial & Community Health

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 16, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations