Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001060932
Ethics application status
Approved
Date submitted
8/02/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effectiveness of an infographic compared to asynchronous e-learning to teach general practice nurses about Chronic Kidney Disease (CKD) risk factors and best practice screening methods
Scientific title
Investigating the effectiveness of an infographic compared to asynchronous e-learning to teach general practice nurses about CKD risk factors and best practice screening methods
Secondary ID [1] 296779 0
None
Universal Trial Number (UTN)
Trial acronym
CKD-DETECT V2.0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 310670 0
Condition category
Condition code
Public Health 309372 309372 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will administer an online infographic that displays the 9 risk factors for CKD (eg: Diabetes, Hypertension, Obesity, smoking) and how to conduct a 'kidney health check' (estimated glomerular filtration rate, urine albumin-creatine ratio, blood pressure) in a graphic (image) form. Administration will be once off. Adherence to the intervention will be monitored by online data analytics in addition to requesting the participant to record their time spent engaging with the infographic. The time to complete the pre and post knowledge surveys, and read the infographic should not exceed 15 minutes
Intervention code [1] 313083 0
Early detection / Screening
Intervention code [2] 316863 0
Treatment: Other
Comparator / control treatment
The control group will undertake an asynchronous online e-learning program, The program profiles a typical case presentation of a patient attending a general practice and uses this to teach CKD risk factors and screening in an interactive manner. This is in contrast to the intervention which is a single page infographic which presents CKD risk factors and screening procedures in a graphic form. Participants undertaking the control and its associated surveys are expected to complete it within 30 minutes. Administration will be once off although participants can log in and log off until they have completed at their convenience
Control group
Active

Outcomes
Primary outcome [1] 308333 0
The composite primary outcome is general practice nurses’ knowledge about CKD risk factors and screening practices using the previously validated CKD knowledge evaluation instrument
Timepoint [1] 308333 0
Immediately post intervention
Secondary outcome [1] 354630 0
The composite secondary outcome is the difference in learning efficiency between the control and the intervention groups. Learning efficiency will be calculated as the knowledge score divided by the total time spent learning as assessed by knowledge evaluation instrument and online data analytics/participant recorded time.
Timepoint [1] 354630 0
Time between pre and post surveys OR participant reported time taken to complete intervention or control if undertaken over multiple sittings assessed immediately post intervention.

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they are currently
working as a general practice nurse in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone who is not currently working as a general practice nurse in Australia

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)
Allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with blocks of randomly varying size (4 or
6)
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/02/2020
Date of last participant enrolment
Anticipated
Actual
28/08/2020
Date of last data collection
Anticipated
Actual
31/08/2020
Sample size
Target
440
Accrual to date
Final
480
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301354 0
University
Name [1] 301354 0
University of Newcastle
Country [1] 301354 0
Australia
Primary sponsor type
University
Name
Univeristy of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 301024 0
None
Name [1] 301024 0
Address [1] 301024 0
Country [1] 301024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302097 0
University of Newcastle HREC
Ethics committee address [1] 302097 0
Ethics committee country [1] 302097 0
Australia
Date submitted for ethics approval [1] 302097 0
16/11/2019
Approval date [1] 302097 0
27/11/2019
Ethics approval number [1] 302097 0
H-2019-0062

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

Contacts
Principal investigator
Name 89098 0
Dr Peter Sinclair
Address 89098 0
Charles Darwin University
College of Nursing & Midwifery, Sydney Campus
Level 9, 815 George Street, HAYMARKET NSW 2000
t: +61 2 8047 4108
Country 89098 0
Australia
Phone 89098 0
+61 2 8047 4108
Fax 89098 0
Email 89098 0
[email protected]
Contact person for public queries
Name 89099 0
Peter Sinclair
Address 89099 0
Charles Darwin University
College of Nursing & Midwifery, Sydney Campus
Level 9, 815 George Street, HAYMARKET NSW 2000
t: +61 2 8047 4108
Country 89099 0
Australia
Phone 89099 0
+61 2 8047 4108
Fax 89099 0
Email 89099 0
[email protected]
Contact person for scientific queries
Name 89100 0
Peter Sinclair
Address 89100 0
Charles Darwin University
College of Nursing & Midwifery, Sydney Campus
Level 9, 815 George Street, HAYMARKET NSW 2000
t: +61 2 8047 4108
Country 89100 0
Australia
Phone 89100 0
+61 2 8047 4108
Fax 89100 0
Email 89100 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
IPD will not be available as permission has not been sought


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.