Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000561482
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
2/05/2016
Date last updated
2/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Poos in ED - The efficacy of different sets of instructions for Polyethylene glycol and electrolytes administration for the treatment of constipation in children presenting to the emergency department.
Scientific title
Healthy Poos in ED Study (A): A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department.
Secondary ID [1] 289079 0
nil
Universal Trial Number (UTN)
U1111-1182-3141
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 298527 0
faecal impaction 298539 0
Condition category
Condition code
Oral and Gastrointestinal 298617 298617 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The extended instructions provide information on how much medication to take, about tips on healthy toileting practices, how the medication works and its mode of action in simple language.
The format of the instructions is in written hard copy fact sheets also with a URL link to a visual version of the same information
The instructions are administered to the relative to at discharge in a sealed envelope (double blinded)
The extended instructions include 1 extra page in the hard copy and 6 extra minutes in the electronic version. Total anticipated time to take approximately 9 minutes to view video and 5 minutes to read paper fact sheet completely, total 14 minutes.
These instructions are provided to parent of child and child.
Intervention code [1] 294588 0
Other interventions
Comparator / control treatment
The standard instructions provide information about how much medication to take, tips on good toileting practice and how the medication works and its mode of action in simple language. The instructions also provide examples and tips of how to assist the child to take the medication.
The format of the instructions is in written hard copy fact sheets also with a URL link to a visual version of the same information
The instructions are administered to the relative to at discharge in a sealed envelope (double blinded)
The standard instructions include 3 pages of content in the hard copy and 3 minute video in the electronic version. Total anticipated time to take approximately 6 minutes to view video version and 5 minutes to read fact sheet completely, total 9 minutes.
These instructions are provided to parent of child and child.
Control group
Active

Outcomes
Primary outcome [1] 298106 0
Patient does not meet Rome 3 criteria for constipation as per clinical assessment conducted by ED doctor
Timepoint [1] 298106 0
The Clinical assessment for meeting Rome 3 criteria will be conducted Day 1 as baseline measure and Day 6 after the instructions were provided.
Secondary outcome [1] 323195 0
The stool volume passed by the patient will be measured by a clinical assessment conducted by a ED doctor.
Timepoint [1] 323195 0
A clinical assessment will be conducted 6 days post instructions
Secondary outcome [2] 323219 0
The Clinical assessment will be conducted to ask patient what stool consistency is according to Bristol Stool Scale.
Timepoint [2] 323219 0
the Clinical assessment to determine stool consistency will be collected at day 1 and collected day 6 post administration of instructions
Secondary outcome [3] 323220 0
a clinical assessment will be conducted to determine the amount of medication taken by asking the participant and carer
Timepoint [3] 323220 0
a clinical assessment will be conducted on Day 6 to determine the amount of medication taken over the previous 6 days
Secondary outcome [4] 323221 0
A Questionnaire on Paediatric Gastrointestinal Symptoms Rome 111 Version (QPGS-R111) will given to participant/carer to determine the quality of life measures.
Timepoint [4] 323221 0
a questionnaire will given to participant/carer at day 1 prior to any medication being taken and day 6 after all clinical measures have been completed.
Secondary outcome [5] 323282 0
The Clinical assessment will be conducted to ask patient what the ease of passage of stool was like
Timepoint [5] 323282 0
The Clinical assessment to ask patient what the ease of passage of stool was like will be done on Day 1 and Day 6
Secondary outcome [6] 323283 0
The Clinical assessment will be conducted to ask patient about stool frequency
Timepoint [6] 323283 0
The Clinical assessment to ask patient about stool frequency will be done on Day 1 and Day 6
Secondary outcome [7] 323284 0
A PedsQL Healthcare satisfaction will given to carer to determine the satisfaction with the treatment provided as part of the study
Timepoint [7] 323284 0
A PedsQL Healthcare satisfaction will given to carer at Day 6 of the study after all the other clincial measures have been completed.

Eligibility
Key inclusion criteria
1. presented to Emergency Department with a principal diagnosis of constipation (must meet Rome 3 criteria for constipation)
2. Is able to receive treatment at home
3. Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
4. Is able to access internet at home to view the video
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known sensitivity to PEG

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our audit of existing practice in the Emergency Department, we assume that, in the control arm (standard instructions, written and verbal), the proportion of participants who no longer meet clinical criteria for Faecal Impaction is 45%. Based on our results testing the extended instructions (written and verbal instructions) in the Emergency Department during our previous trial, this proportion is expected to exceed 60% (assumed effect size: odds ratio 1.83). In order to detect this difference at two-sided 0.05 level of significance with a statistical power of 80%, 173 participants per group, are needed. In order to compensate for potential drop-outs and treatment protocol deviators within a supportive per-protocol analysis, a total of 400 individuals (200 subjects within each intervention arm) will be included in the trial.
Following intention-to-treat principles, participants will be analysed as randomised. A binary logistic regression analysis will be used for the evaluation of the primary study endpoint. The factor variable age (as defined by the stratification variable categories) will be used as an adjustment variable within the analysis. Multiple imputations will be used to impute missing outcome data. The primary confirmatory analysis will be conducted at a two sided 0.05 level of significance. The difference in proportions of patients meeting the primary outcome definition (standard vs extended instructions arm) will be computed based on the logistic regression model and reported as effect measures along with a 95% confidence interval.

Interim Analyses
There will be no formal interim analysis for the primary efficacy endpoint. Safety data i.e. incidence of SAE & SUSAR as well as quality of data collected will be continuously examined, however, every 3 months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5681 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 293455 0
University
Name [1] 293455 0
Victoria University
Country [1] 293455 0
Australia
Primary sponsor type
Hospital
Name
Royal Childrens Hospital
Address
50 Flemington Road Parkville, 3152 Victoria
Country
Australia
Secondary sponsor category [1] 292277 0
Other Collaborative groups
Name [1] 292277 0
Murdoch Childrens Research Institute
Address [1] 292277 0
50 flemington rd, Parkville 3152 Vicoria
Country [1] 292277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294899 0
royal childrens hospital
Ethics committee address [1] 294899 0
50 flemington road Parkville, 3152 Victoria
Ethics committee country [1] 294899 0
Australia
Date submitted for ethics approval [1] 294899 0
30/11/2015
Approval date [1] 294899 0
12/04/2016
Ethics approval number [1] 294899 0
35178

Summary
Brief summary
A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes (PEG+E) in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department (ED).
This study aims to compare effectiveness of two different sets of instructions provided with PEG+E for paediatric faecal impaction treatment in an ED.
This is a single-centre, prospective, randomised controlled trial of two instructions (standard instructions vs. extended instructions) provided in both written and video for the intake of PEG+E treatment.
Primary: Main symptom improvement, remission from the inclusion criteria at day 6 post study treatment initialization as rated by the participant or his/her guardian.
Secondary: stool frequency/consistency/ease of stool passage and stool volume (questionnaires)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65394 0
Dr Bridget Southwell
Address 65394 0
Murdoch Childrens Research Institute
Flemington road, Parkville Victoria 3152
Country 65394 0
Australia
Phone 65394 0
+613 9345 5069
Fax 65394 0
Email 65394 0
[email protected]
Contact person for public queries
Name 65395 0
Ms Julie Jordan-Ely
Address 65395 0
Royal Childrens Hospital
50 Flemington Rd, Parkville 3152 Victoria
Country 65395 0
Australia
Phone 65395 0
+613 99366793
Fax 65395 0
Email 65395 0
[email protected]
Contact person for scientific queries
Name 65396 0
Dr Bridget Southwell
Address 65396 0
Murdoch Childrens Research Institute
50 Flemington Rd, Parkville 3152 Victoria
Country 65396 0
Australia
Phone 65396 0
+61393455069
Fax 65396 0
Email 65396 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

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