- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01708304
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs) (RDAD)
2017년 9월 14일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
510
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: RDAD
Exercise training for caregiver and care recipient.
Behavior modification training for caregiver.
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Exercise training for caregiver and care recipient.
Behavioral modification training for caregiver.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Minutes of exercise per week
기간: Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
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Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
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Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
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Restricted Activity Days
기간: Baseline
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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.
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Baseline
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Restricted Activity Days
기간: Change from Baseline to Pre-Treatment (6 weeks)
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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.
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Change from Baseline to Pre-Treatment (6 weeks)
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Restricted Activity Days
기간: Change from Baseline to Post- Treatment 1 (13 weeks)
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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.
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Change from Baseline to Post- Treatment 1 (13 weeks)
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Restricted Activity Days
기간: Change from Baseline to Post-Treatment 2 (30 weeks)
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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.
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Change from Baseline to Post-Treatment 2 (30 weeks)
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Restricted Days of Activity
기간: Change from Baseline to 13 Month Follow-Up
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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.
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Change from Baseline to 13 Month Follow-Up
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Independence/Residential Status
기간: Change from Baseline to 13 Month Follow-Up
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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.
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Change from Baseline to 13 Month Follow-Up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Revised Memory and Behavior Problem Checklist (RMBPC)
기간: Baseline
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Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Baseline
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Revised Memory and Behavior Problem Checklist (RMBPC)
기간: Change from Baseline to Pre-Treatment (6 weeks)
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Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Change from Baseline to Pre-Treatment (6 weeks)
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Revised Memory and Behavior Problem Checklist (RMBPC)
기간: Change from Baseline to Post-Treatment 1 (13 weeks)
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Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Change from Baseline to Post-Treatment 1 (13 weeks)
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Revised Memory and Behavior Problem Checklist (RMBPC)
기간: Change from Baseline to Post-Treatment 2 (30 weeks)
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Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Change from Baseline to Post-Treatment 2 (30 weeks)
|
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Revised Memory and Behavior Problem Checklist (RMBPC)
기간: Change from Baseline to 13 Month Follow-Up
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Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
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Change from Baseline to 13 Month Follow-Up
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Quality of Life-AD
기간: Baseline
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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.
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Baseline
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Quality of Life-AD
기간: Change from Baseline to Pre-Treatment (6 weeks)
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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.
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Change from Baseline to Pre-Treatment (6 weeks)
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Quality of Life-AD
기간: Change from Baseline to Post-Treatment 1 (13 weeks)
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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.
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Change from Baseline to Post-Treatment 1 (13 weeks)
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Quality of Life-AD
기간: Change from Baseline to Post-Treatment 2 (30 weeks)
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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.
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Change from Baseline to Post-Treatment 2 (30 weeks)
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Quality of Life-AD
기간: Change from Baseline to 13 Month Follow-Up
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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.
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Change from Baseline to 13 Month Follow-Up
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CES-D
기간: Baseline
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This 20-item scale that assesses depression in caregivers.
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Baseline
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CES-D
기간: Change from Baseline to Pre-Treatment (6 weeks)
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A 20-item scale that assesses depression in caregivers.
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Change from Baseline to Pre-Treatment (6 weeks)
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CES-D
기간: Change from Baseline to Post-Treatment 1 (13 weeks)
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A 20-item scale that assesses depression in caregivers.
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Change from Baseline to Post-Treatment 1 (13 weeks)
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CES-D
기간: Change from Baseline to Post-Treatment 2 (30 weeks)
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A 20-item scale that assesses depression in caregivers.
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Change from Baseline to Post-Treatment 2 (30 weeks)
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CES-D
기간: Change from Baseline to 13 Month Follow-Up
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A 20-item scale that assesses depression in caregivers.
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Change from Baseline to 13 Month Follow-Up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Linda Teri, Ph.D., University of Washington
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 11월 1일
기본 완료 (실제)
2017년 6월 1일
연구 완료 (실제)
2017년 6월 1일
연구 등록 날짜
최초 제출
2012년 10월 9일
QC 기준을 충족하는 최초 제출
2012년 10월 15일
처음 게시됨 (추정)
2012년 10월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 14일
마지막으로 확인됨
2017년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
RDAD에 대한 임상 시험
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University of WashingtonNational Institute on Aging (NIA)완전한