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Feasibility Of Sleep Treatment Education in Stroke Rehabilitation Settings (FOSTERS)

6. November 2026 aktualisiert von: University of Oxford

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Before sleep package implementation - patients

Usual care prior to delivery of sleep package
Aktiver Komparator: After sleep package implementation - patients

Usual care plus sleep package
Sonstiges: Sleep education package

Staff and patients will receive sleep resources and staff will receive sleep training
Kein Eingriff: After sleep package implementation - staff

Staff sleep training implementation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Staff perceptions of the usefulness of sleep education package
Zeitfenster: 2 months following enrolment

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
Staff perceptions of the relevance of the sleep education package
Zeitfenster: 2 months following enrolment

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
Staff perceptions of the appropriateness of the sleep education package
Zeitfenster: 2 months following enrolment

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
Patient perceptions of the usefulness of the sleep education package
Zeitfenster: 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.

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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient perceptions of acceptability of measures that staff use to support sleep
Zeitfenster: 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.

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.
Self-reported sleep
Zeitfenster: 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.

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.
Sleep disruption
Zeitfenster: 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.

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.
Sleep related impairment
Zeitfenster: 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.

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.
Sleep disturbance
Zeitfenster: 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.

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.
Perception of sleep quality
Zeitfenster: 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.

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.
Sleep environment
Zeitfenster: 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.

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.
Mood
Zeitfenster: 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.

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.
Fatigue
Zeitfenster: 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.

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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Oxford

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

3. November 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

6. November 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2026

Zuerst gepostet (Tatsächlich)

13. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PID19474
  • NIHR207158 (Andere Zuschuss-/Finanzierungsnummer: UK National Institute for Health Research)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Anonymous data will be shared upon request to the principal investigator

IPD-Sharing-Zeitrahmen

Following publication of study results

IPD-Sharing-Zugriffskriterien

Anonymous data will be shared by contacting the principal investigator

Art der unterstützenden IPD-Freigabeinformationen

  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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