Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
2015년 5월 6일 업데이트: RAND
Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers.
New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them.
These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.
연구 개요
연구 유형
중재적
등록 (실제)
144
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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California
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Sylmar, California, 미국, 91342-1495
- Olive View-UCLA Medical Center
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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
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Caregivers of persons with dementia
- Caregivers must either live with the care recipient (person with dementia) or be the identified primary support
- Caregiver relationship must have been present for the prior 6 months
- Caregivers must have telephone access
- Caregivers must speak English or Spanish
- Care recipients must have a prior dementia diagnosis
- Care recipients must be living in the community other than a nursing facility
Exclusion Criteria:
- Persons with dementia, lacking an informal caregiver who can communicate in Spanish or English, or living in a long term care facility
- Caregiver lacks the capacity to consent to study participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Dementia care management in person
The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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활성 비교기: Dementia care management telephone only
The dementia care management protocol will be delivered via telephonic meetings only.
Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Caregiver Burden at 6 and 12 Months
기간: 0, 6 and 12 months
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The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia.
Originally a 29-item instrument, the 22-item modified version is easily completed by telephone.
This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden.
Higher Zarit scores indicate greater caregiver burden.
The minimum possible score is 0, and the maximum possible score is 110.
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0, 6 and 12 months
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Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
기간: 0, 6 and 12 months
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The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues.
The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week.
Higher RMBPC scores mean worse memory/behavior problems.
The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.
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0, 6 and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Caregiver Depression at 6 and 12 Months
기간: 0, 6 and 12 months
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The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks.
The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders.
It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day).
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0, 6 and 12 months
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Change in Caregiver Quality of Life at 6 and 12 Months
기간: 0, 6 and 12 months
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The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish.
Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.
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0, 6 and 12 months
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Change in Care Recipient Quality of Life at 6 and 12 Months
기간: 0, 6 and 12 months
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The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population.
The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.
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0, 6 and 12 months
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Change in Process Measures of Dementia Care Quality at 6 and 12 Months
기간: 0, 6 and 12 months
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The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.
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0, 6 and 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 수석 연구원: Joshua Chodosh, M.D., MSHS, RAND
- 수석 연구원: Barbara Vickrey, M.D., MPH, RAND
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
2011년 3월 1일
기본 완료 (실제)
2013년 10월 1일
연구 완료 (실제)
2013년 10월 1일
연구 등록 날짜
최초 제출
2011년 1월 18일
QC 기준을 충족하는 최초 제출
2011년 10월 25일
처음 게시됨 (추정)
2011년 10월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 6일
마지막으로 확인됨
2015년 5월 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. .
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록
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