- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02682472
SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
SettleIN - An Adjustment to Care Intervention for People With Dementia: A Feasibility Pilot Study in Care Homes
Admission into a care home for people with dementia has been linked with both positive and negative psychological outcomes for both the resident and their carers. Whilst some people with dementia adjust quickly, many never adjust at all or adjustment is complex and linked to cognitive and behavioural decline (Wilson et al, 2007). Therefore, support for healthy adjustment is needed.
Recent research (Aminzadeh et al., 2013; Sury, Burns and Brodaty, 2013, Sussman and Dupuis, 2013) has identified factors that influence different relocation outcomes and prevent adverse reactions. There are currently no interventions that support successful adjustment by emphasising the positive factors found to influence relocation outcomes while mitigating the effects of negative influences and addressing any missed pre-admission procedures, reported in the literature.
The current project seeks to design an intervention that predominantly builds on the work of Sury et al (2013) and focuses on promoting healthy adjustment through an enhanced best practice based admission process.
The intervention will be developed through systematic review of the literature and consultation with professional experts, service users, care home staff and carers. The current study will serve as a feasibility (pilot) study and test the acceptability of the intervention design, examine recruitment and dropout and establish sample size for future, larger studies. It also aims to examine whether the intervention indicates an improvement in residents' quality of life, mood, overall adjustment and carer satisfaction with care.
All participants will receive a subset of the same intervention, specifically tailored to their needs and with elements delivered by staff, carer or psychologist. Staff and researchers will assess the improvement indicators mentioned above using relevant psychometric measures at baseline, post intervention completion and at one-month follow up. Indirect measures (interviews and staff field notes) will also be used to indicate intervention fidelity and feasibility.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Janine Hayward
- 이메일: janine.hayward.13@ucl.ac.uk
연구 연락처 백업
- 이름: Aimee Spector
- 이메일: a.spector@ucl.ac.uk
연구 장소
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London, 영국
- 모병
- Multiple UK Care Home locations
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연락하다:
- Janine Hayward
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Site:
- Within Greater London
- At least one resident who has been recently admitted to care (ideally within the previous fortnight and no more than one month after admission).
- Sufficient cover to allow at least 1 staff lead to attend a half-day training
- Managerial assurance of adequate resources allowing staff participation
Resident sample:
- Meet diagnostic criteria for dementia according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V, APA, 2013)
- Score between FAST stage 2 and 6 representing a range of mild to moderately severe dementia on The Functional Assessment Staging Test (FAST, Reisberg, 1987)
- Be able to communicate in English
Staff sample:
• Working as a Nurse (registered nurses of any grade, student nurses) or Care Assistant (Health Care Assistants and nursing assistants).
DSM Criteria will be confirmed by formal diagnosis or use of the FAST as a screen.
Exclusion Criteria:
Site:
• Participation in any other research study
Resident sample:
• Score FAST stage 7 equating to severe dementia on The Functional Assessment Staging Test (FAST, Reisberg, 1987)
Staff sample:
• Lack of availability on training, intervention delivery and assessment dates
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: SettleIN
SettleIN - Adjustment to care programme intervention
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A programme for care home staff to support new residents with dementia quickly and successfully adjust to life in a care home
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The primary outcome measure is change in residents' quality of life and measured by the Quality of Life in Alzheimer's Disease (QOL-AD, Lodgson et al, 1996) which will be administered by researchers.
기간: Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up
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Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aimee Spector, UCL London
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 15/0201
- 15/LO/0611 (기타 식별자: NRES Committee London - Camden & Kings Cross)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
SettleIN - Adjustment to care programme에 대한 임상 시험
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