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Trial registered on ANZCTR


Registration number
ACTRN12619001531101
Ethics application status
Approved
Date submitted
2/10/2019
Date registered
6/11/2019
Date last updated
6/11/2019
Date data sharing statement initially provided
6/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial exploring the administration of intravenous antibiotics and fluids via intravenous pole and pump versus portable CADD pump to improve mobility in patients diagnosed with cancer (The Active Trial)
Scientific title
A Randomised Controlled Trial exploring the administration of intravenous antibiotics and fluids via intravenous pole and pump versus portable CADD pump to improve mobility in patients diagnosed with cancer (The Active Trial)
Secondary ID [1] 298188 0
None
Universal Trial Number (UTN)
Trial acronym
The Active Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility 312773 0
Patient outcomes 315020 0
Hospital-acquired complications 315021 0
Condition category
Condition code
Cancer 311271 311271 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive intravenous antibiotics (IVABs)/intravenous (IV) fluids via a Computerised Ambulatory Delivery Device (CADD) pump. The CADD pump is a small, battery-powered infusion pump that promotes mobility by delivering IV medication/fluids without the need for an IV pole. It is connected to the patient's Central Venous Access Device (CVAD) and is stored in a small, carry bag and travels with the patient as they mobilise and perform activities of daily living. Participants will receive the prescribed IVAB/fluids as a continuous, 24 hour infusion for a maximum treatment period of seven (7) days. CADD pump adherence will be documented via the CADD pump observations chart in the comments/variances section, to be completed by nursing staff every 4 hours. This document will be reviewed by the research nurse daily.
Intervention code [1] 314422 0
Treatment: Devices
Comparator / control treatment
The control group will receive IVABs/IV fluids via the standard IV pole and pump system. Participants will receive their IVAB intermittently, at the times prescribed by the treating team e.g. four (4)times per day, for a maximum of seven (7) days.
Control group
Active

Outcomes
Primary outcome [1] 320074 0
The primary outcome of this study is level of mobility for inpatients diagnosed with cancer as assessed by number of steps per day counted using an accelerometer device.
Timepoint [1] 320074 0
Data (no. of steps) will be captured for the length of the course of IVABs, i.e., up to seven (7) days, or course of IV fluids. The outcome will be measured at seven (7) days or sooner depending on length of treatment or early discharge from hospital.
Secondary outcome [1] 370450 0
Sleep disturbance will be assessed via the Patient Sleep Disturbance survey (a. PROMIS V1.0 - Sleep Disturbance – Short Form 6a).
Timepoint [1] 370450 0
The PROMIS V1.0 - Sleep Disturbance – Short Form 6a survey will be completed daily by participants until completion of involvement in the trial.
Secondary outcome [2] 370451 0
Patient Quality of Life (QOL) will be assessed via the Patient QOL survey (PROMIS) V1.2 – Global Health questionnaire.
Timepoint [2] 370451 0
The PROMIS V1.2 – Global Health questionnaire will be completed by patients at the beginning and end of involvement in the trial.
Secondary outcome [3] 370452 0
Hospital-acquired complications (falls, thrombus formation and embolism, infection, antimicrobial resistance, pressure injuries & medication errors) will be captured via the progress notes, medication chart and from discussions with the treating team and nursing staff. Data will be verified against the RBWH RiskMan Incident Reporting System.
Timepoint [3] 370452 0
Data will be captured at 48 hours post patient involvement in the trial.

Eligibility
Key inclusion criteria
1. Medical oncology inpatients with a CVAD,
2. Patients 18 years of age and over,
3. Patients with a Glasgow Coma Scale (GCS) of 15,
4. Patients prescribed an IVAB and IV fluids suitable for continuous infusion over 24-hours
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients that are immobile, bed-bound, require spinal cord precautions, or have oxygen requirements when mobilising.
2. Patients that are isolated due to contact, droplet or airborne precautions (i.e. have tested positive for MRSA, VRE, C-Diff, Influenza A & B, Parainfluenza, RSV, Adenovirus or Norovirus).


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who provide informed consent will be randomised once they have been prescribed an IVAB/IV fluids by the treating doctor. The registered nurse will randomise patients by selecting 1 sealed opaque envelope from the randomisation kit and will allocate the patient to the arm indicated in the envelope. The envelopes will be in sequential order to ensure that appropriate randomisation occurs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation list will be created using the Sealed Envelope website. Randomisation will be on a 1:1 ratio between groups with varied block sizes of 4, 6 and 8.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This Randomised Controlled Trial (RCT) is a two-group design to compare the IV pole and pump (standard care/control group) to the CADD pump (intervention group) in terms of mobility, patient outcomes and hospital-acquired complications in inpatients diagnosed with cancer.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size and study power:

To the best of our knowledge, no data exists regarding the number of steps people with a cancer diagnosis take when hospitalised. This has presented challenges with performing sample size calculations.

A study of hospitalised patients who were 65 years of age or older without cancer reported patients walked a mean of 585 (Standard Deviation [SD] 738) steps per day. The literature also reveals that walking at least 900 steps per day is associated with better outcomes. In the absence of any reliable data to perform sample size calculations, it was arbitrarily assumed that the population of patients in the oncology ward, who are generally older, would walk around 585 steps per day. Sample size calculations were based on the aim of walking at least 900 steps per day.

As steps taken per day is a count data, it is reasonable to assume that it would have a Poisson distribution, where the SD is the same as the mean. Using the conventional approach to sample size calculations of a Type 1 error set at 0.05 and power of at least 80%, we determined a sample size of 110 was adequate (55 patients in each arm). The limitations of this approach are recognised and the calculations are estimates only.

Data analysis:

Descriptive statistics will be computed for all study variables to describe the sample and check for missing data. Categorical/dichotomous variables will be examined via frequencies and percentages. Central tendency and distribution will be calculated for continuous data. Means with standard deviation are presented for continuous variables and proportions (%) for categorical variables. The grand mean of steps for every patient will be measured as the mean steps from the ActiGraph activity monitor on all the patient’s valid monitored days.

Univariate statistics will be used to compare differences between the outcome variables between the control and intervention group. T-tests will be computed for the mean or median steps walked depending on distribution of the data.

Multivariable linear regression will be performed for the primary outcome with clinically important variables forced in the model. Generalised linear models will be used as appropriate for the data (i.e., normal or Poisson dependent on error distribution). The purpose of covariable adjustment in randomised trials is not to adjust for imbalance in baseline differences (which should be accounted for in the study design). Rather, this adjustment is to gain efficiency in the analyses by subtracting unexplained variation which serves to increase the power of the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26487 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 302728 0
Hospital
Name [1] 302728 0
Royal Brisbane and Women's Hospital
Address [1] 302728 0
Butterfield Street, Herston QLD 4029
Country [1] 302728 0
Australia
Funding source category [2] 304149 0
University
Name [2] 304149 0
Queensland University of Technology
Address [2] 304149 0
Victoria Park Road, Kelvin Grove QLD 4059
Country [2] 304149 0
Australia
Funding source category [3] 304150 0
University
Name [3] 304150 0
University of Queensland
Address [3] 304150 0
St Lucia, Qld 4072
Country [3] 304150 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 302661 0
None
Name [1] 302661 0
Address [1] 302661 0
Country [1] 302661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303334 0
Royal Brisbane and Women's Human Research Ethics Committee
Ethics committee address [1] 303334 0
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 303334 0
Australia
Date submitted for ethics approval [1] 303334 0
10/07/2019
Approval date [1] 303334 0
16/08/2019
Ethics approval number [1] 303334 0
HREC/2019/QRBW/53863

Summary
Brief summary
The purpose of this study is to compare the currently used IV pole and pump to a smaller, portable IV pump, called a CADD pump, for the administration of IV antibiotics and IV fluids.

You may be eligible for this study if you are aged 18 years or over and are a cancer inpatient who has been prescribed intravenous antibiotics or fluids.

Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will use the CADD pump to receive their IV antibiotics/fluids, and the other group will use the existing IV pole and pump system. All participants will wear a step-counter, called an accelerometer, on their wrist. Patients will be asked to consent to the study by a research nurse and will be required to answer some brief questionnaires during their involvement in the study.

It is hoped this research will show that the CADD pump helps inpatients to be more mobile in hospital, and that this will lead to improved patient outcomes and reduced hospital-acquired complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93310 0
Dr Nicole Gavin
Address 93310 0
Level 2, Building 34, Centre for Clinical Nursing
Royal Brisbane & Women’s Hospital,
Herston QLD 4029
Country 93310 0
Australia
Phone 93310 0
+610736465833
Fax 93310 0
Email 93310 0
nicole.gavin@health.qld.gov.au
Contact person for public queries
Name 93311 0
Dr Nicole Gavin
Address 93311 0
Level 2, Building 34, Centre for Clinical Nursing
Royal Brisbane & Women’s Hospital,
Herston QLD 4029
Country 93311 0
Australia
Phone 93311 0
+610736465833
Fax 93311 0
Email 93311 0
nicole.gavin@health.qld.gov.au
Contact person for scientific queries
Name 93312 0
Dr Nicole Gavin
Address 93312 0
Level 2, Building 34, Centre for Clinical Nursing
Royal Brisbane & Women’s Hospital,
Herston QLD 4029
Country 93312 0
Australia
Phone 93312 0
+610736465833
Fax 93312 0
Email 93312 0
nicole.gavin@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not ethically approved.
What supporting documents are/will be available?
No other documents available
Summary results
No Results