Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000859482p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Towards Sleeping in GARU: A Multi-Phase Analysis of Sleep in the Geriatric and Rehabilitation Unit
Scientific title
Development and Feasibility of a Multi-Phase Sleep Hygiene Intervention to Improve Sleep Quality in the Geriatric and Rehabilitation Unit
Secondary ID [1] 314564 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 337560 0
Geriatric rehabilitation 337561 0
Condition category
Condition code
Public Health 333913 333913 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted at the Princess Alexandra Hospital Geriatric and Rehabilitation Unit (GARU) in Brisbane, Queensland.
Stage 1: Co-design of Sleep Intervention.
Study design: The co-design process will be guided by the Double Diamond framework, a structured, multi-phase approach that incorporates both divergent and convergent thinking. Developed by the UK Design Council in 2005, this framework has been widely applied in co-design research. It consists of four key phases: Discover, which involves exploring problems and gathering insights; Define, where problems are refined; Develop, which focuses on generating and exploring solutions; and Deliver, where solutions are tested and evaluated. The co-design phase will use a modified Delphi methodology combined with structured workshops to generate an intervention protocol. This iterative, consensus-driven approach is ideal for generating stakeholder agreement on complex interventions in clinical settings.
Co-design process - Delphi survey and Workshops:
Delphi survey rounds
• Round 1: Open-ended questions distributed electronically to generate broad ideas around sleep disruption and potential intervention strategies. Questions will be informed by preliminary findings.
• Round 2: Stakeholders will rank the feasibility and importance of consolidated strategies identified from Round 1.
• Round 3: Stakeholders will re-rank items, informed by group feedback, aiming for consensus (>70% agreement).
Following the completion of the Delphi rounds, a series of structured, in-person or virtual co-design workshops will be conducted to further develop and refine the proposed intervention components. These workshops will employ Nominal Group Techniques (NGT) to facilitate equitable participation among all stakeholder groups, including clinicians, Nurse Unit Managers (NUMs), allied health professionals, Queensland University of Technology (QUT) built environment architect scientists, and patient consumers. Through a structured process of idea generation, discussion, and private ranking, NGT will support consensus on the most practical, acceptable, and contextually appropriate strategies to be incorporated into the intervention. The outcomes of these sessions will be synthesised into a preliminary intervention protocol, which will outline operational details such as intervention timing, delivery processes, staff responsibilities, and required resources. This collaborative refinement process ensures the protocol remains aligned with stakeholder priorities while maintaining feasibility within the specific operational constraints of the GARU environment.
Data management and analysis plan
Statistical analysis: Thematic and descriptive analysis of qualitative survey and structured group discussion responses to identify consensus-driven intervention components.
Ethical considerations for participants: Study period: This co-design study will progress from September 2025 to December 2025 and will commence recruitment and participation as soon as appropriate HREC and SSA approvals are obtained.

Stage 2: Feasibility and acceptability trial of Intervention
Study design: This study is a 4-week feasibility and acceptability trial using a mixed-methods evaluation, incorporating quantitative outcomes and qualitative feedback. Prior to the trial, a 2-week Plan-Do-Study-Act (PDSA) cycle will be conducted to iteratively test and refine interventions, ensuring they are optimised before full implementation. Notably, a longer testing period may be needed to fully refine the protocol to allow for adequate feasibility/ acceptability of the intervention. The PDSA methodology, widely used in healthcare improvement, allows for real-time adjustments based on staff and patient feedback, enhancing both feasibility and acceptability. This iterative approach ensures interventions are practical, patient-centred, and adaptable to the complexities of real-world clinical settings.
Outcome Measures:
1. Feasibility: protocol adherence, Recruitment rate (target: greater than or equal to 50% of eligible participants), retention rate.
2. Acceptability: Participant/staff satisfaction surveys (5-point Likert scale).
3. Preliminary Efficacy: Pre-post change in PSQI scores (target: greater than or equal to 3-point reduction).
4. Intervention Barriers/Enablers: Semi-structured interviews with staff and patients.
Implementation: The co-designed intervention will be implemented in GARU, targeting environmental (light, noise), behavioural (sleep hygiene and sleep education), and clinical (minimising overnight disruption) elements. The co-designed intervention is likely to be multicomponent and will be considerate of available funding. Environmental strategies may include noise reduction measures such as the use of rubber stoppers on equipment, enforcement of quiet hours, and staff reminders to reduce loud conversations. Earplugs may be offered where safe, alongside light optimisation strategies like dimmable bedside lighting, use of eye masks, and warm light torches for overnight checks. Room allocation may be adapted to relocate patients who are frequently disturbed and to prioritise natural light access for less mobile individuals. White noise machines may also be explored for feasibility.

At the behavioural and patient level, interventions may include structured daytime activity schedules to promote circadian alignment - such as morning mobilisation, outdoor time, and evening wind-down routines. Patients may be encouraged to reduce evening screen exposure and engage in relaxing alternatives like audiobooks or music. Sleep hygiene education tailored to cognitive capacity will also be explored.
Clinical and workflow strategies may involve reviews of medications that interfere with sleep, and preference for non-pharmacological approaches. Night-time care may be optimised through the clustering of nursing tasks, minimising overnight vital sign checks where clinically appropriate, and timing toileting rounds to reduce disruptions. Additionally, sleep quality and disturbances may be discussed during morning clinical handovers to better inform daily care planning.
Staff and system-level strategies will also be critical. Brief training modules may be provided to build awareness of geriatric sleep needs, supported by case studies or simulations. Sleep champions may be designated on each shift to foster a unit culture supportive of sleep, and incentives or recognition systems could reinforce best practice. Integration of sleep into care plans, therapy goals, and discharge summaries will help embed sleep as a core component of patient wellbeing. Finally, sleep experience questionnaires may be completed on discharge, allowing feedback from patients and families to inform ongoing improvements.
Most of these interventions will be implemented with aid by nursing staff, with key roles also played by allied health professionals (particularly in daytime activity and sleep education) and medical staff (especially in medication review and clinical oversight). Adherence to the intervention will be monitored using brief ward-level tools such as sleep-focused checklists, updates recorded in clinical handovers, and documentation in the medical record or allied health notes, depending on the nature of the intervention. These strategies aim to ensure both fidelity and flexibility, allowing for iterative refinement as part of the feasibility trial.
Study period: This co-design study will progress approximately from December 2025 to March 2026 and will commence recruitment and participation only when appropriate HREC and SSA approvals are obtained.
Intervention code [1] 331119 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341551 0
Primary outcome: 1. To assess the feasibility of implementing the intervention by evaluating protocol adherence, recruitment rates, and study retention.
Timepoint [1] 341551 0
4 weeks post-intervention commencement - Protocol adherence, recruitment rate, and retention rate will be determined at the end of the study enrolment period
Primary outcome [2] 342094 0
2. To determine the acceptability of the intervention among participants and staff. note: composite primary outcome
Timepoint [2] 342094 0
- Participant/staff satisfaction acceptability surveys will be provided 1-2 weeks post-intervention commencement
Primary outcome [3] 342095 0
3. To identify systemic barriers and enablers to implementation through qualitative feedback from stakeholders. note: composite primary outcome
Timepoint [3] 342095 0
- Semi-structured interviews with patients and staff will occur 4 weeks post-intervention commencement
Secondary outcome [1] 447910 0
To explore preliminary efficacy through pre- and post-intervention changes in PSQI scores.
Timepoint [1] 447910 0
4 weeks post-intervention commencement

Eligibility
Key inclusion criteria

Phase 1 inclusion criteria: The study will involve a range of key stakeholders from the Geriatric and Rehabilitation Unit (GARU), including clinicians, nurses, allied health professionals, and patient consumers. For healthcare professionals - namely clinicians, nurses, and allied health staff - the inclusion criterion is current or recent experience providing care within the GARU setting. Individuals not directly involved in clinical care will be excluded. To ensure maximum variation sampling, participants will be purposively selected based on discipline and years of experience. Patient consumers will include current inpatients or individuals recently discharged from the GARU within the past six months. Eligible participants must be over 18 years of age and have the capacity and willingness to provide informed consent.
Phase 2 inclusion criteria: Willing GARU inpatients and staff able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase 1 exclusion criteria: Exclusion criteria include lack of fluency in English where an interpreter is required but not available. Variation among consumers will be sought based on key demographic and clinical characteristics to ensure a diversity of perspectives.
Phase 2 exclusion criteria: GARU inpatients not fluent in English for whom an interpreter is required but not available, patients <18 years of age, and patients with significant cognitive impairment precluding participation Intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27968 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 44160 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 44161 0
4102 - Buranda

Funding & Sponsors
Funding source category [1] 319038 0
Hospital
Name [1] 319038 0
Princess Alexandra SERTA grant
Country [1] 319038 0
Australia
Primary sponsor type
Individual
Name
Dr Claire Ellender, Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 321503 0
None
Name [1] 321503 0
Address [1] 321503 0
Country [1] 321503 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317646 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 317646 0
Ethics committee country [1] 317646 0
Australia
Date submitted for ethics approval [1] 317646 0
20/05/2025
Approval date [1] 317646 0
Ethics approval number [1] 317646 0
pending

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141682 0
A/Prof Claire M. Ellender
Address 141682 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba 4170. Queensland
Country 141682 0
Australia
Phone 141682 0
+61 7 3176 2698
Fax 141682 0
Email 141682 0
[email protected]
Contact person for public queries
Name 141683 0
Olivia Dunstan
Address 141683 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba 4170. QLD
Country 141683 0
Australia
Phone 141683 0
+61 7 3176 2698
Fax 141683 0
Email 141683 0
[email protected]
Contact person for scientific queries
Name 141684 0
Olivia Dunstan
Address 141684 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba 4170. QLD
Country 141684 0
Australia
Phone 141684 0
+61 7 3176 2698
Fax 141684 0
Email 141684 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.