Feasibility Of Sleep Treatment Education in Stroke Rehabilitation Settings (FOSTERS)
Stroke is a leading cause of disability with over 1 million people in the UK living with the effects of stroke. Sleep is important for many aspects of daily life, but there is growing evidence that people sleep worse after a stroke, and this impacts negatively on rehabilitation outcomes and quality of life. Stroke survivors have highlighted to us that it is difficult to sleep in the hospital after a stroke, and they feel that sleep isn't perceived as high priority despite clear importance for next day function and healing.
This project will develop and test a sleep education package for clinical staff and stroke survivors in the rehabilitation hospital. Specifically, we aim to (1) develop a training programme for staff and a toolkit of resources about sleep for staff and stroke survivors, (2) assess acceptability and usability of the package, and, following modifications, (3) assess the feasibility of delivery of the sleep education package and collecting data about patient's sleep.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Melanie K Fleming, PhD
- 전화번호: +441865611461
- 이메일: melanie.fleming@ndcn.ox.ac.uk
연구 연락처 백업
- 이름: Julie Darbyshire, PhD
- 이메일: julie.darbyshire@ucl.ac.uk
연구 장소
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Oxford, 영국
- 모병
- Oxfordshire Stroke Rehabilitation Unit
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연락하다:
- Melanie Fleming
- 전화번호: +441865611461
- 이메일: melanie.fleming@ndcn.ox.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Stroke survivors:
- Neurorehabilitation unit inpatient
- Clinical diagnosis of stroke
- Aged 18 years or over
- Willing and able to provide informed consent OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice.
Staff:
- Current stroke rehabilitation unit staff member, providing care to stroke survivors
- Aged 18 years or over
- Able and willing to provide informed consent
Exclusion Criteria:
- Staff may not participate if they are anticipated to be leaving the neurorehabilitation unit within 2 months of the delivery of the sleep education package
- Stroke survivors may not participate if they are anticipated to be discharged within 1 week of recruitment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Before sleep package implementation - patients
Usual care prior to delivery of sleep package |
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활성 비교기: After sleep package implementation - patients
Usual care plus sleep package |
Staff and patients will receive sleep resources and staff will receive sleep training |
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간섭 없음: After sleep package implementation - staff
Staff sleep training implementation |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Staff perceptions of the usefulness of sleep education package
기간: 2 months following enrolment
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Proportion of staff who received the sleep package rating the package as useful, using a likert scale 4-point rating from 1=no definitely not, to 4=yes definitely |
2 months following enrolment
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Staff perceptions of the relevance of the sleep education package
기간: 2 months following enrolment
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Proportion of staff who received the sleep package rating the package as relevant, using a 4-point likert scale from 1=no definitely not, to 4=yes definitely |
2 months following enrolment
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Staff perceptions of the appropriateness of the sleep education package
기간: 2 months following enrolment
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Proportion of staff who received the sleep package rating the package as appropriate, using a 4-point likert scale from 1=not appropriate at all, to 4=very appropriate |
2 months following enrolment
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Patient perceptions of the usefulness of the sleep education package
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Proportion of patients who received the sleep package rating the package as useful. 10-point Likert scale rating for usefulness of resources, from 1=not useful at all, to 10=very useful. |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient perceptions of acceptability of measures that staff use to support sleep
기간: At discharge from rehabilitation unit (exact time from enrolment varies between participants depending on the length of their clinical stay in the rehabilitation hospital). Typically 1-4 weeks from enrolment.
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Likert scale rating of how acceptable they found measures that staff were using to try to support their sleep, from 1=not acceptable at all, to 10=very acceptable. |
At discharge from rehabilitation unit (exact time from enrolment varies between participants depending on the length of their clinical stay in the rehabilitation hospital). Typically 1-4 weeks from enrolment.
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Self-reported sleep
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep assessed using the Sleep Condition Indicator questionnaire (SCI), from 0-32, with higher values indicating better sleep |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep disruption
기간: Continuous from recruitment till discharge from the rehabilitation unit. The exact timeframe will differ between participants depending on the length of their clinical stay in the rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Assessed using actigraphy (wearable activity monitor) over the duration of their stay in hospital from enrolment to discharge. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts <=1min".There are no units associated with sleep fragmentation. |
Continuous from recruitment till discharge from the rehabilitation unit. The exact timeframe will differ between participants depending on the length of their clinical stay in the rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep related impairment
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep assessed using the Sleep related impairment questionnaire (SRI). Each question is scored from 1 to 5, yielding a raw total sum score from 8 to 40. Higher raw numbers mean worse daytime impairment. Raw scores are translated into a T-score using official lookup tables. Interpreting the T-Score: 50 or lower: Normal or better-than-average wakefulness/55 to 59 (0.5 to 1.0 SD above mean): Mild sleep-related impairment/60 to 69 (1.0 to 2.0 SD above mean): Moderate sleep-related impairment/70 or higher (2.0+ SD above mean): Severe sleep-related impairment. |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep disturbance
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep assessed using the Sleep disturbance questionnaire (SD). 5-point Likert scale (1 = never to 5 = always) covering the past 7 days. Sum the raw scores (range 8-40) and use a standard look-up conversion table to change the raw total into a standardized T-score (mean = 50, standard deviation = 10). T-Score Interpretation: < 55: None to slight sleep disturbance/55.0 - 59.9: Mild sleep disturbance/60.0 - 69.9: Moderate sleep disturbance/70 and over: Severe sleep disturbance |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Perception of sleep quality
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep assessed using the Richards-Campbell Sleep questionnaire. Scored by measuring 5 visual analog scale items from 0 to 100 millimeters. Each item score is summed and divided by 5 to yield a total score from 0 (worst sleep) to 100 (best sleep), with scores under 50 indicating poor sleep. |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep environment
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Sleep assessed using the sleep environment questionnaire (ASE). The Assessment of Sleep Environment (ASE) is a 13-item self-report questionnaire. Each item is rated on a 4-point Likert scale from 0 to 3 ("strongly disagree" to "strongly agree"). Summing all items yields a total score from 0 to 39, where higher scores reflect a more disruptive, poorer sleep environment. |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Mood
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Mood assessed using the Patient Health Questionnaire (PHQ8). Each item is rated from 0 to 3 based on how often symptoms occurred over the past two weeks. Total scores range from 0 to 24. 0-4: No significant depressive symptoms/5-9: Mild symptoms/10-14: Moderate symptoms (a score of 10 or greater often indicates probable major depression)/15-19: Moderately severe symptoms/20-24: Severe symptoms |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Fatigue
기간: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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Fatigue assessed using the Fatigue Severity Scale (FSS). Scores are evaluated by calculating the total sum (9 to 63) or the average mean (1 to 7). A mean score of 4.0 or higher (or a total sum of 36 or more) indicates clinically significant fatigue |
At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- PID19474
- NIHR207158 (기타 보조금/기금 번호: UK National Institute for Health Research)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymous data will be shared upon request to the principal investigator
IPD 공유 기간
Following publication of study results
IPD 공유 액세스 기준
Anonymous data will be shared by contacting the principal investigator
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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