Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001484235
Ethics application status
Approved
Date submitted
15/08/2018
Date registered
4/09/2018
Date last updated
15/03/2022
Date data sharing statement initially provided
3/10/2019
Date results provided
15/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
eADVICE (electronic Advice and Diagnosis Via the Internet following Computerised Evaluation), an interactive eHealth program addressing paediatric urinary incontinence for reducing waiting times in paediatric urinary incontinence outpatient clinics
Scientific title
Effect of eADVICE (electronic Advice and Diagnosis Via the Internet following Computerised Evaluation), an interactive eHealth program on reducing the proportion of families needing to attend paediatric urinary incontinence outpatient clinics
Secondary ID [1] 294978 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
incontinence in children 307983 0
Condition category
Condition code
Renal and Urogenital 307019 307019 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
eADVICE (electronic Advice and Diagnosis Via the Internet following Computerised Evaluation), an interactive eHealth program that provides treatment advice to patients, supervised by their general practitioner (GP), while they are awaiting a specialist appointment. eADVICE facilitates the exchange of information between the child, parents and specialists using a virtual character (“avatar”), enabling assessment, diagnosis and provision of individualised treatment advice.
The referring doctor will be informed about their patient's study participation, and be invited to help in managing the child’s incontinence. As this research study is a randomised controlled trial, a computerised program will allocate some families to be given access to eADVICE straight away and some families will need to wait 6 months before they can have access. The family will be asked to complete a short online questionnaire about their child’s wetting and previous treatments used, as well as the impact of the incontinence on their life. (they will each take about 3-5 minutes to complete). The family will be asked to answer these questions again at 6 months and 12 months.
For those who have been allocated to access eADVICE straight away, the study coordinator will give the family an ID number and they will be able to set their own unique password to access eADVICE program for 6 months. For those allocated to access at 6 months after referral, they will be required to wait for 6 months before being given an ID number to access eADVICE program which they will be able to use for 6 months.
The eADVICE program will ask detailed questions about their child’s health and continence (similar to the questions they would be asked when attending the continence clinic) and the child's response will trigger specific advice about how to manage their child’s specific problem. Advice include advice on fluid intake, reduced caffeine intake, timed voiding, bowel program, enuresis alarm training and medication use. They will then have opportunity to access the program and enter more information every 2 weeks over the 6 month access period, and the program will tailor the treatment advice according to their child’s response. The child’s information will also be accessible to the child’s referring doctor. The program will only provide advice; it will be up to the family whether they choose to follow this advice. The advice may include the use of medication. If this occurs, the program will inform the doctor and ask the family to speak with them about it. It will be up to the doctor to decide whether medication is necessary.
Treatment adherence will be monitored when the child revisits the program, by the program specifically asking the child whether they followed each of the advice given at the previous visit (always, sometimes, never) and their treatment response .
Once the ID number and password have been given, there is no restriction on the number of fortnights they can access the web page during their 6 month access period. After 6 months they will no longer be able to use the ID and password to access the web page. This is the final part of the study.
We will first test eADVICE in incontinence because clinics for this condition have a waiting time of over 12 months.
Intervention code [1] 301305 0
Treatment: Other
Comparator / control treatment
In the initial 6 months of the study, the control will not receive any treatment from the program. However, participants are free to seek additional treatment and support from health professionals (as this is what normally happens when someone is on an outpatient waiting list). 6 months after their referral to the study, participants in the control group will be given access to eADVICE-continence for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 305998 0
The composite primary outcome is the proportion of families who no longer need or wish to be seen in the clinic at 6 months post referral. Families will be contacted via phone/email/letter at 6 months by the trial coordination to ask whether they still wish to be seen at the continence clinic (yes/no).
Timepoint [1] 305998 0
6 months after enrolment in the study. For the intervention group, this would be 6 months after being given access to the online program. For the control group, this would be after 6 months waiting before they are given access to the online program.
Secondary outcome [1] 347263 0
1. Change in frequency of wetting from baseline - families will be asked in an online survey "how many times in the past 3 months has your child wet" and response will be compared with response from baseline.
Timepoint [1] 347263 0
This will be measured at 6 and 12 months for all participants.

For 6 months: - for the intervention group, this would be at the end of treatment (6 months after being given access to eADVICE). For the control group, this would be after 6 months of waiting before being given access to eADVICE.

For 12 months - for the intervention group, this would be at follow up, 6 months after cessation of access to eADVICE and for the control group, this would be at the end of treatment (6 months after being given access to eADVICE).
Secondary outcome [2] 349206 0
2. Time to achieve 14 consecutive dry days/nights. This would be assessed as the time from commencement of the study until when patients indicate that they have achieved 14 consecutive dry days and nights (measured as the first reporting of 14 consecutive dry days/night according to the online eADVICE program when families revisit the program and also measured at 6 and 12 month on the online questionnaire which asks whether the child has achieved 14 consecutive dry days/night )
Timepoint [2] 349206 0
The timepoints at which this would be measured are: at each subsequent visit to the online eADVICE program and also at 6 and 12 month after enrolment
Secondary outcome [3] 349207 0
3. Adverse effects will be assessed by asking families "were there any problems or side effects with the treatment" (yes/no) with opportunity to provide text explanation. There are generally very few side effects with the treatment. Previous reported known adverse events include "sleep disruption to the family with alarm training", "dry mouth with use of medication". We will not be using any tools or tests to assess for possible adverse effects but will use text analysis of responses.
Timepoint [3] 349207 0
This will be measured at 6 and 12 months post enrolment.
Secondary outcome [4] 349208 0
4. Quality of life will be measured by a modified PinQ (paediatric incontinence questionnaire).
Timepoint [4] 349208 0
This will be measured at baseline and at 6 and 12 months post enrolment.
Secondary outcome [5] 349209 0
5. Qualitative data about reasons why families do not need to attend the clinic (to ensure that reduction in need reflects true and long term benefit of the program). Families will be contacted via phone/email/letter at 6 months by the trial coordination to ask whether they still wish to be seen at the continence clinic, and why it is now not necessary for those who do not wish to be seen at the clinic (whether the child is now dry or for another reason). Reasons will be recorded verbatim and grouped according to themes
Timepoint [5] 349209 0
This will be measured at 6 and 12 months post enrolment.
Secondary outcome [6] 349211 0
6. Total number of visits to the clinic by 6 and 12 months from time of referral This will be measured by counting the number of times the patient has attended the incontinence clinic as recorded in attendance data at the hospital.
Timepoint [6] 349211 0
This will be measured at 6 and 12 months from enrolment.
Secondary outcome [7] 349212 0
7. Cost incurred from total clinic visits at 12 months. This will be calculated from MBS billing data.
Timepoint [7] 349212 0
This will be measured at 12 months from enrolment.
Secondary outcome [8] 349213 0
8. Cost savings from not needing to attend the clinic will be calculated from the mean MBS costs for the intervention and control groups (from MBS billing data)
Timepoint [8] 349213 0
This will be measured at 12 months from enrolment.
Secondary outcome [9] 349214 0
10. PREMS (Patient Reported Experience Measures) survey: Satisfaction with the service received by parent and chil (time spent waiting; access to the service; ability to navigate it; involvement in decision making; knowledge of the care plan and pathways; quality of communication; support to manage the child’s continence from the time parents perceived their child needed professional help; whether parents would recommend the service to family and friends). This is a composite secondary outcome. It will be measured in an online survey to generate a composite score reflecting the family's overall reported experiences and satisfaction.
Timepoint [9] 349214 0
This will be measured at 6 and 12 months
Secondary outcome [10] 349215 0
11. Tool validation after access to eADVICE-continence. This will be assessed in an online survey designed specifically for this study
Timepoint [10] 349215 0
This will be measured at 6 months for the intervention group and at 12 months for the control group.
Secondary outcome [11] 351361 0
9. Number of clinic visits to achieve continence. This will be calculated from the number of visits to the clinic to achieve 14 consecutive dry days/nights for each group.
Timepoint [11] 351361 0
This will be measured at 12 months.
Secondary outcome [12] 351365 0
12. Usability of eADVICE-continence for families. This will be assessed by an online survey designed specifically for this study..
Timepoint [12] 351365 0
This will be measured at 6 months for the intervention group and at 12 months for the control group.
Secondary outcome [13] 351366 0
13. Program usage (frequency and timing of access and by whom) will be assessed by monitoring the website for the frequency and timing of program access and what pages were accessed.
Timepoint [13] 351366 0
This will be measured at 6 months for the intervention group and at 12 months for the control group.
Secondary outcome [14] 351368 0
14. Therapeutic alliance (how well the patient interacts and feels aligned with the computer program will be measure using an online survey. We will use a validated survey, the modified Short Revised Working Alliance Inventory.
Timepoint [14] 351368 0
This will be measured at 6 months for the intervention group and at 12 months for the control group.
Secondary outcome [15] 351369 0
15. Adherence to program will be measured by the eADVICE program each time the family revisits the program (which asks whether they followed each of the specific treatment advice: never, some of the time or most of the time).
Timepoint [15] 351369 0
This will be measured at 6 months for the intervention group and at 12 months for the control group.
Secondary outcome [16] 351371 0
Referring doctor user experience. This is a composite secondary outcome which comprise questions around whether doctors' accessed the website to review information about their patients, the ease of use of the website, their satisfaction with the online program, any concerns about the program and whether they would use it for other patients, with opportunity to provide detailed feedback in text format. It will be measured by an online survey to referring doctors designed specifically for this study.
Timepoint [16] 351371 0
This will be measured at 12 months after enrolment.

Eligibility
Key inclusion criteria
Children with urinary incontinence aged 5 to 18 years who do not have a neurological or urological cause for their incontinence and can self-initiate toileting are eligible for the study. Referral letters to the clinics will be screened and potentially eligible patients will be contacted by our study coordinator and invited to the study.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Neurological or urological cause for their incontinence

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)
central randomisation by computer
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The main analysis (led by A/Prof Amando Teixeira-Pinto, one of the investigators in this project who is an Associate Professor of Biostatistics at the Sydney School of Public Health) will be by intention-to-treat. Descriptive results will be presented as percentages and counts for discrete variables, and as mean and standard deviation or median and interquartile range for quantitative variables, according to their distribution. Balance of baseline characteristics between the two arms will be checked. If important differences are observed, the comparisons of the outcomes will additionally be adjusted for the respective characteristics.
The proportion of patients achieving improvement in the two arms will be compared using a Chi-square or logistic regression if adjustment is required for baseline differences. The change in frequency of wetting, the quality of life score and number of visits to the clinic will be compared using a Mann-Whitney test. The time to achieve 14 consecutive days will be analysed with Kaplan-Meier curves and log-rank test. The significance level for all tests will be set at 0.05. No correction for multiple comparisons will be made for the analyses of primary and secondary outcomes. Missing data will be multiple imputed, where appropriate. Exploratory subgroup analysis will be considered by testing interactions in linear models for continuous outcomes and logistics regression for binary ones.
.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
19/02/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
15/12/2020
Date of last data collection
Anticipated
31/12/2021
Actual
31/01/2022
Sample size
Target
230
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11669 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 11670 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 11671 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 23716 0
2145 - Westmead
Recruitment postcode(s) [2] 23717 0
2031 - Randwick
Recruitment postcode(s) [3] 23718 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 299567 0
Government body
Name [1] 299567 0
TRANSLATIONAL RESEARCH GRANTS SCHEME, NSW Health
Country [1] 299567 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital Westmead
Address
The Children's Hospital Westmead
Hawkesbury Rd
Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 299477 0
None
Name [1] 299477 0
Address [1] 299477 0
Country [1] 299477 0
Other collaborator category [1] 280230 0
Hospital
Name [1] 280230 0
Sydney Children's Hospital
Address [1] 280230 0
High St
Randwick, NSW, 2031
Country [1] 280230 0
Australia
Other collaborator category [2] 280231 0
Hospital
Name [2] 280231 0
John Hunter Children's Hospital
Address [2] 280231 0
Lookout Rd
New Lambton Heights, NSW, 2305
Country [2] 280231 0
Australia
Other collaborator category [3] 280299 0
Hospital
Name [3] 280299 0
John Hunter Hospital
Address [3] 280299 0

Lookout Road

NEW LAMBTON HEIGHTS NSW 2305
Country [3] 280299 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300464 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 300464 0
Ethics committee country [1] 300464 0
Australia
Date submitted for ethics approval [1] 300464 0
22/08/2018
Approval date [1] 300464 0
01/11/2018
Ethics approval number [1] 300464 0

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

Contacts
Principal investigator
Name 83746 0
A/Prof Patrina Caldwell
Address 83746 0
The Children's Hospital at Westmead
Hawkesbury Rd, Westmead, NSW, 2145
Country 83746 0
Australia
Phone 83746 0
+61 407436192
Fax 83746 0
Email 83746 0
[email protected]
Contact person for public queries
Name 83747 0
Patrina Caldwell
Address 83747 0
The Children's Hospital at Westmead
Hawkesbury Rd, Westmead, NSW, 2145
Country 83747 0
Australia
Phone 83747 0
+61 407436192
Fax 83747 0
Email 83747 0
[email protected]
Contact person for scientific queries
Name 83748 0
Patrina Caldwell
Address 83748 0
The Children's Hospital at Westmead
Hawkesbury Rd, Westmead, NSW, 2145
Country 83748 0
Australia
Phone 83748 0
+61 407436192
Fax 83748 0
Email 83748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
we will no be making IPD available.


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
SourceTitleYear of PublicationDOI
EmbaseA Randomized Controlled Trial of a Web-Based Management Support System for Children with Urinary Incontinence: The eADVICE Trial.2023https://dx.doi.org/10.1097/JU.0000000000003832
N.B. These documents automatically identified may not have been verified by the study sponsor.