Authors
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Prince of Wales Hospital -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: This is a hybrid type II feasibility randomised control trial and therefore has two separate intervention components: 1) the implementation strategies delivered by the research team to physiotherapists to enable them to use the clinical intervention (digitally enabled rehabilitation) in practice; and 2) the clinical intervention (digitally enabled rehabilitation) delivered by physiotherapists to people undertaking inpatient aged care and neurological rehabilitation. Implementation strategies: The COM‐B model of behaviour change has been used to design the implementation strategies to address the identified barriers to implementation identified from the AMOUNT trial and related qualitative work (access to devices, lack of training and support to use devices, IT problems). The COM‐B intervention functions to be used include education, training, enablement, and environmental restructuring. A clinical champion who is a clinical physiotherapist at the site will be identified and trained by the Chief Investigator (Physiotherapist, Manager of parent AMOUNT trial (ACTRN12614000936628), who developed the original intervention protocol) and research physiotherapist (delivered intervention in parent AMOUNT trial (ACTRN12614000936628) in the use of digital devices and the intervention protocol. Digital devices will be loaned to the study site. The physiotherapy team will be provided with resources (e.g., intervention protocol) and face‐to‐face education and training through two workshops held approximately three months apart. The first workshop will be run for about 3 hours by the Chief Investigator and the research physiotherapist who conducted the phase 1 (ACTRN12614000936628) of this study at least 6 months before the trial is open for patient recruitment. The workshops CONDITION: Mobility limitations ;Physical inactivity; ; Mobility limitations; ; Physical inactivity Neurological ‐ Other neurological disorders Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: Feasibility outcome: Average number of participants recruited into the study per week determined from the screening log. Feasibility criteria: nil.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Average total active time in minutes per day using digital devices for mobility tasks collected from digital device and usual care practice sheets (both groups). Feasibility criteria: average of > or = 30mins per day for >50% intervention participants; 0mins per day for >90% control participants (to confirm no contamination). [At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Percentage of usual care (both groups) and digital device (intervention group only) practice sheets complete and legible, These practice sheets are completed by clinical physiotherapists and detail the type and amount of exercises done in rehabilitation with and without the use of digital devices respectively. Feasibility criteria: complete sheets for > or = 85% participants.[At the end of the trial ‐ after the last enrolled participant has completed the trial.] SECONDARY OUTCOME: Feasibility outcome: Hours spent by Clinical Champion and study investigators in staff training. This will be collected using the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number and cost of devices and consumables (e.g., data cards) needed throughout the implementation phase and trial, recorded using an equipment management log.[At the end of the trial ‐ after the last enrolled participant has completed the trial.] Feasibility outcome: Number of days over 3‐week intervention that digital devices were not used by participants randomised to the intervention group and why? This will be collected from the digital devices practice sheets.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of devices that dosage data was successfully retrieved from. This will be collected from digital devices practice sheets.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of lost or broken devices needing replacement throughout the implementation phase and trial, recorded using an equipment management log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of participants who have a 3‐week assessment completed (primary outcome measure) prior to discharge between 2‐4 weeks post randomisation. This will be collected from REDCap study completion form. Feasibility criteria: > or = 85% completed for all outcome measures except physical activity (> or = 80%).[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of physiotherapists and physiotherapy students that were trained over the course of project and the number of hours spent training them in using digital devices. This will be recorded in the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of staff trained and conducting screening, recruitment and outcome assessment. This will be collected using the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of times the devices did not work, time needed to fix it, how and who fixed it and the cost of fixing it. This will be collected using equipment management log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Number of training sessions missed by staff and students and the reasons why? This will be collected in the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Percentage of participants each mobility task was trained with digital devices. This will be collected using digital devices practice sheets.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Percentage of participants in the intervention group that used each digital device. This will be collected from digital devices practice sheets.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Percentage of staff trained that participated in prescribing and delivering rehabilitation using digital devices. This will be collected using the staff training log and digital device practice sheets. [At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Proportion of patient screened who were eligible and ineligible, and reasons why they were ineligible, collected from screening log.[At the end of the trial ‐ after the last enrolled participant has completed the trial.] Feasibility outcome: Proportion of people screening who were eligible who declined taking part in the study and the reasons why they decline. This will be collected from the screening log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Total number of FTE staff within physiotherapy rehabilitation team that are participating in the trial. This will be collected using the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Total number of training activities performed (workshops, journal clubs, clinical reasoning sessions and audit and feedback). This will be collected from the staff and students training log.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Feasibility outcome: Who collected and how was dosage data collected for technology use? This will be collected from the digital devices practice sheets.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Implementation determinants: Change in physiotherapists Capability, Opportunity and Motivation to prescribing and delivering rehabilitation using digital devices, measured using a study specific questionnaire, developed based upon the COM‐B self‐evaluation questionnaire. [End of workshop 1 and workshop 2, and during implementation period. ] Patient level outcome: Activity Measure for Post Acute Care (AM‐PAC) 12 item version.[Baseline and 3 weeks post randomisation] Patient level outcome: Adverse events: Falls and fall related injuries (from hospital incident reporting ; system)[Baseline to end of inpatient stay] Patient level outcome: Average steps per day measured over a 3‐day period (1 day at ; INCLUSION CRITERIA: Patients receiving the clinical intervention: Adults admitted to the Prince of Wales Hospital for rehabilitation with • reduced mobility (Short Physical Performance Battery score of less than 12/12) • a clinician‐assessed capacity for improvement in mobility • a likely life expectancy of more than 6 months, estimated by a score of three or less on a modified version of the Implicit Illness Severity Scale • an anticipated length of stay of at least 3 weeks from the date of randomisation ; baseline) using the StepWatch activity monitor[Baseline and 3 weeks post randomisation] Patient level outcome: Number and type of adverse events when using digital devices in practice. This will collected using the Adverse events collection form.[At the end of the trial ‐ after the last enrolled participant has completed the trial] Patient level outcome: Quality of life: EQ5D‐5L[Baseline and 3 weeks post randomisation] Patient level outcome: Short Physical Performance Battery (SPPB) (continuous version), ; also known as the lower extremity continuous summary performance score, which uses actual time taken to complete mobility tasks. Scores range from 0 (worst performance) to 3 (best performance) and are based on timed gait speed over 4‐m, standing balance with feet positioned parallel, semi‐tandem and tandem, and standing up from a chair five times. The continuous version has been suggested as more likely to be able to detect change than the 12‐point version. ; [Baseline and 3 weeks post randomisation] Patient level outcome: Step test, number of times the participant is able to step one foot on, then off, a 7.5cm block as quickly as possible in 15secs. The average number of steps between the two legs is the variable calculated.[Baseline and 3 weeks post randomisation] Patient level outcome: Timed single leg stance (max 10 seconds).[Baseline and 3 weeks post randomisation] Patient level outcome; Maximal balance range test measuring maximum anterior posterior displacement in mm.[Baseline and 3 weeks post randomisation] Patient‐level outcome: Mobility task performance will be measured using the 12‐point (total score and subscale scores) of the Short Physical Performance Battery (SPPB). The SPPB is a composite performance‐based measure of gait, sit‐to‐stand and standing balance. ; The secondary outcome measure 29, 'The SPPB', is a composite score while the secondary outcome measure 1, Short Physical Performance Battery (SPPB) also known as the lower extremity continuous summary performance score is a continuous score and will be reported as two separate scores and the reason why both are mentioned here, Though they sound similar, they are different. ; [At baseline and 3 weeks post randomisation.] Qualitative outcome measure: Focus Groups ‐ to capture the experiences and attitudes of physiotherapists delivering digitally‐enabled rehabilitation.[Towards the end of the trial. ] Therapists receiving the implementation strategies and delivering the clinical intervention: Eligible therapists will be physiotherapists employed within SESLHD who provide inpatient rehabilitation to people with decreased mobility in the Rehabilitation ward (Parks 1 West) of Prince of Wales Hospital.
Epistemonikos ID: 8aa39120c03482af2206f59e070003335bc2838c
First added on: Aug 25, 2024