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)

Not Applicable

• Conditions: Mobility; Patient outcomes; Hospital-acquired complications; Cancer - Any cancer

• Registration Number: ACTRN12619001531101
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Study Completion: 2024-05-07
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1.Medical oncology and haematology 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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>[ 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 Measures

Name	Time	Method
Sleep disturbance will be assessed via the Patient Sleep Disturbance survey (a.PROMIS V1.0 - Sleep Disturbance – Short Form 6a).[ The PROMIS V1.0 - Sleep Disturbance – Short Form 6a survey will be completed daily by participants until completion of involvement in the trial.];Patient Quality of Life (QOL) will be assessed via the Patient QOL survey (PROMIS) V1.2 – Global Health questionnaire. [ The PROMIS V1.2 – Global Health questionnaire will be completed by patients at the beginning and end of involvement in the trial.];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. [ Data will be captured at 48 hours post patient involvement in the trial. ]