- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02953574
Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosis of dementia of any severity and type
- Allocation to geriatric rehabilitation treatment
Exclusion Criteria:
- sleep related respiratory or moving related disorders or Parasomnia
- delirium
- end of life care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: daily sleep enhancement nursing protocol
A 7 step nursing protocol. Each step is daily provided to the demented patient through a nurse by bedtime. Step 1: serve a late snack Step 2: evening care (brush teeth, get pyjama on, go to toilette) Step 3: note and treat physical circumstances that restrain sleep (pain, obstipation,...) Step 4: ensure comfortable position abed Step 5: assist to eliminate stressful situation (calm, reorientating conversation) Step 6: turn off the light Step 7: care for a silent environment (turn off Television, radio and "do not disturb"-sign at the door) |
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간섭 없음: usual nursing care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bedtime in minutes
기간: Daily for up to 14 days from date of giving informed consent to hospital discharge
|
Protocol of daily bedtime
|
Daily for up to 14 days from date of giving informed consent to hospital discharge
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
기간: Every second day for up to 14 days from date of giving informed consent to hospital discharge
|
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC) Scale:
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Every second day for up to 14 days from date of giving informed consent to hospital discharge
|
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Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
기간: Every second day for up to 14 days from date of giving informed consent to hospital discharge
|
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC) Scale:
|
Every second day for up to 14 days from date of giving informed consent to hospital discharge
|
|
Cognitive performance (Mini-mental-status-test score)
기간: Once in first three days after giving informed consent and another time 7 or 14 days later
|
Mini-mental-status-test score (range 0-30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment |
Once in first three days after giving informed consent and another time 7 or 14 days later
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Physical performance measured with the Handgrip strength test
기간: Once in first three days after giving informed consent and another time 7 or 14 days later
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Handgrip strength in Pascal
|
Once in first three days after giving informed consent and another time 7 or 14 days later
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Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
기간: day 1,2 and day 6,7 or 13,14
|
Medical charts review for sedative neuroleptics (e.g.
Quetiapine, Haloperidol), sedative antidepressives (e.g.
Trazodon), hypnotics present (Benzodiazepines, benzodiazepine-like drugs) in the time between 18:00-24:00 (nominal variable: yes or no )
|
day 1,2 and day 6,7 or 13,14
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Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
기간: day 7 or 14
|
Domicile after hospital discharge
|
day 7 or 14
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Application frequency of the nursing (ritual) protocol
기간: Every day for up to 14 days from date of giving informed consent to hospital discharge
|
Daily protocol of the received and of the refused interventions of the nursing ritual (frequency)
|
Every day for up to 14 days from date of giving informed consent to hospital discharge
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hanna Burkhalter, Dr. sc. med., Center of Sleep Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 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. .