Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000398606
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bladder control problems after hip surgery
Scientific title
Continence promotion following surgical repair of fractured neck of femur in older hospital patients.
Secondary ID [1] 162 0
National Continence Management Scheme: NCMS Round 4, No.21
Universal Trial Number (UTN)
Trial acronym
#NOF H2O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incontinence 504 0
Condition category
Condition code
Renal and Urogenital 582 582 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-dimensional continence management intervention is planned, with three main components:
1. For each patient in the intervention group, a CNC will apply an evidence-based bladder management clinical pathway to audit patients needs and engage a multidisciplinary team in meeting these needs. The CNC will also monitor the team's response and follow up to ensure appropriate action has occurred.
2. A patient education booklet detailing promotion of bladder and bowel function following fractured NOF.
3. Education and motivation sessions will be provided across the multi-disciplinary provider team (eg, nurses, physiotherapists, occupational therapists, medical practitioners, dietitians), to ensure the team are enabled to respond appropriately.

The Intervention will run for 6 months, from August 2005 to February 2006.
Intervention code [1] 391 0
Prevention
Comparator / control treatment

Usual care will be provided for control patients.
Control group
Active

Outcomes
Primary outcome [1] 675 0
Continence Status, as measured by self-report interview
Timepoint [1] 675 0
At 5 days, 12 weeks and 12 months post #NOF surgery, and medical record audit.
Secondary outcome [1] 1382 0
Interviews will assess: bladder urgency, nocturia, symptom frequency and severity, drugs known to promote urinary incontinence/ urgency.
Timepoint [1] 1382 0
5 day, 12 week,12 month
Secondary outcome [2] 1383 0
Review of patient records will assess: surgical anaesthesia (drug, dose, delivery), length of surgery, postoperative pain management, urinary retention, bladder management strategies(eg, catheterisation), symptomatology or diagnosis of urinary tract infections.
Timepoint [2] 1383 0

Eligibility
Key inclusion criteria
Participants are patients 60 years and older admitted to John Hunter Hospital for surgical fixation of fractured neck of femur.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor cognitive status (participants must be able to answer the survey questions), and poor general medical condition (as assessed by NUM).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will perceive treatment as
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers were generated in SAS V9.1.3 using the RANUNI function with fixed seed. The resulting uniform distribution of random numbers was verified visually by graphing. Study numbers were ordered according to the order of the random numbers from largest to smallest. Alternating batches of 20 study numbers were sequentially selected to be allocated to either the intervention or control group. This continued until 50% of study numbers had been allocated to the intervention group and 50% to the control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 635 0
Government body
Name [1] 635 0
National Continence Management Scheme
Country [1] 635 0
Australia
Primary sponsor type
Individual
Name
Dr Pauline Chiarelli
Address
Country
Secondary sponsor category [1] 519 0
Individual
Name [1] 519 0
Dr Lynne Parkinson
Address [1] 519 0
Country [1] 519 0
Secondary sponsor category [2] 520 0
Individual
Name [2] 520 0
Professor Julie Byles
Address [2] 520 0
Country [2] 520 0
Secondary sponsor category [3] 521 0
Individual
Name [3] 521 0
Ms Wendy Watts
Address [3] 521 0
Country [3] 521 0
Secondary sponsor category [4] 522 0
Individual
Name [4] 522 0
Ms Gillian Lloyd
Address [4] 522 0
Country [4] 522 0
Secondary sponsor category [5] 523 0
Individual
Name [5] 523 0
Ms Suzanne McNeill
Address [5] 523 0
Country [5] 523 0
Secondary sponsor category [6] 524 0
Individual
Name [6] 524 0
Professor Kichu Nair
Address [6] 524 0
Country [6] 524 0
Secondary sponsor category [7] 525 0
Individual
Name [7] 525 0
Dr Lynette Mackenzie
Address [7] 525 0
Country [7] 525 0
Secondary sponsor category [8] 526 0
Individual
Name [8] 526 0
Ms Rhonda Walker
Address [8] 526 0
Country [8] 526 0
Secondary sponsor category [9] 527 0
Individual
Name [9] 527 0
Dr Janine Duke
Address [9] 527 0
Country [9] 527 0
Secondary sponsor category [10] 528 0
Individual
Name [10] 528 0
Mr Richard Gibson
Address [10] 528 0
Country [10] 528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1767 0
John Hunter Hospital
Ethics committee address [1] 1767 0
Newcastle, NSW
Ethics committee country [1] 1767 0
Australia
Date submitted for ethics approval [1] 1767 0
Approval date [1] 1767 0
Ethics approval number [1] 1767 0

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

Contacts
Principal investigator
Name 36144 0
Address 36144 0
Country 36144 0
Phone 36144 0
Fax 36144 0
Email 36144 0
Contact person for public queries
Name 9580 0
Dr Pauline Chiarelli
Address 9580 0
Physiotherapy
School of Health Sciences
Faculty of Health
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 9580 0
Australia
Phone 9580 0
+61 2 49216046
Fax 9580 0
Email 9580 0
[email protected]
Contact person for scientific queries
Name 508 0
Dr Lynne Parkinson
Address 508 0
Centre for Research and Education in Ageing
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 508 0
Australia
Phone 508 0
+61 2 49236232
Fax 508 0
+61 2 49236323
Email 508 0
[email protected]

No information has been provided regarding IPD availability


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.