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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Sleep education package

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie K Fleming, PhD; Phone Number: +441865611461; Email: melanie.fleming@ndcn.ox.ac.uk
• Study Contact Backup: Name: Julie Darbyshire, PhD; Email: julie.darbyshire@ucl.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Recruiting
    • Oxfordshire Stroke Rehabilitation Unit
    • Contact: Melanie Fleming; Phone Number: +441865611461; Email: melanie.fleming@ndcn.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Before sleep package implementation - patients; Usual care prior to delivery of sleep package
Active Comparator: After sleep package implementation - patients; Usual care plus sleep package	Other: Sleep education package; Staff and patients will receive sleep resources and staff will receive sleep training
No Intervention: After sleep package implementation - staff; Staff sleep training implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff perceptions of the usefulness of sleep education package	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	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	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient perceptions of acceptability of measures that staff use to support sleep	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	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	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	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start (Estimated): November 3, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: PID19474; NIHR207158 (Other Grant/Funding Number: UK National Institute for Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Anonymous data will be shared upon request to the principal investigator

IPD Sharing Time Frame

Following publication of study results

IPD Sharing Access Criteria

Anonymous data will be shared by contacting the principal investigator

• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No