Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001360303
Ethics application status
Approved
Date submitted
18/09/2017
Date registered
27/09/2017
Date last updated
14/02/2020
Date data sharing statement initially provided
14/02/2020
Date results provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Using e-learning and the theory of planned behaviour to predict behavioural intention in Chronic Kidney Disease screening practices in Australian primary health care nurses: A randomised controlled trial
Scientific title
Using e-learning and the theory of planned behaviour to predict behavioural intention in Chronic Kidney Disease screening practices in Australian primary health care nurses: A randomised controlled trial
Secondary ID [1] 292909 0
Nil known
Universal Trial Number (UTN)
U1111-1202-2557
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 304761 0
Condition category
Condition code
Renal and Urogenital 304084 304084 0 0
Kidney disease
Public Health 304156 304156 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a single blinded pre-post interventional randomised controlled trial design to evaluate the effectiveness of an asynchronous internet based e-learning module on Australian primary health care nurses’ knowledge and behavioural intentions in relation to opportunistic screening practices in people at risk of Chronic Kidney Disease (CKD). Participants will be randomised to either an active control (e-learning module focused on CKD screening knowledge only) or intervention arm (interactive e-learning module focused on barriers to opportunistic CKD screening and information related to potential solutions. 9 challenges related to CKD risk identification and screening were identified in a previous study that informed the intervention. Practical solutions to these challenges were developed and delivered by a team of primary health care nurses using a variety of multimedia and other resources in the intervention. The participant identifies which challenges are relevant to them and follows a pathway that presents potential solutions that are specific to their needs). Given that the intervention is an online asynchronous e-learning program it can be completed by participants at any time or any place that is convenient to them as long as they have access to the internet. The intervention was designed in collaboration with primary health care nurses and peer reviewed by nurse educators, nurse practitioners, academics and other key stakeholders in kidney health in Australia. Participants undertaking the active control are expected to complete the module in 60 minutes. Participants undertaking the intervention are expected to complete the intervention within 90 - 150 minutes depending on their level of knowledge on CKD screening (determined by an online survey (i.e. knowledge quiz) prior to starting intervention module. Intervention adherence or fidelity will not be directly assessed as part of this study due to the independent and interactive nature of the intervention which is pragmatic and allows participants to identify challenges that are exclusive and tailored to their personal needs. Participants will not be able complete post intervention surveys unless they have completed the entire e-learning module assigned to them.
Intervention code [1] 299144 0
Early detection / Screening
Intervention code [2] 299145 0
Behaviour
Comparator / control treatment
The control arm will be exposed to a case study focused internet based e-learning module that focuses on two learning outcomes:
1. Identify the major risk factors for developing CKD
2. Describe the best practice screening method for CKD
Control group
Active

Outcomes
Primary outcome [1] 303406 0
Behavioural intention as assessed by the Theory of Planned Behaviour Chronic Kidney Disease Identification and Screening Questionnaire
Timepoint [1] 303406 0
Within one week of completion
Secondary outcome [1] 338855 0
Primary health care nurses’ perceived satisfaction with an asynchronous web based e-learning module evaluated using the Learner Satisfaction with asynchronous e-Learning tool
Timepoint [1] 338855 0
Upon completion of module/s
Secondary outcome [2] 338856 0
Primary health care nurses’ knowledge about CKD risk factors and screening practices using a CKD knowledge evaluation tool
Timepoint [2] 338856 0
Upon completion of module

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they are currently working as a nursing aligned health care professional (i.e. practice nurse) in a primary health care 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 nursing aligned health care professional (i.e. practice nurse) in a primary health care 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)
Central randomisation by computer program
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), stratified by rurality and years of experience (< 10 years or 10+ years).
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
Sample size calculation was performed using Stata version 14 (Statacorp, College Station, TX). Based on a power of 0.80 with a two sided a of 0.05 and assuming a mean standardised effect size of (Cohen’s d) 0.3 the study will require a total of 110 participants per group (220 in total). This calculation assumes a baseline/follow-up correlation of 0.6. Assuming attrition up to 20%, we need to recruit 140 per group (280 in total). A sample of this size is achievable as there are currently 4000 practice nurses registered with the APNA. Assuming a consent rate of 20% this means this means a sample of 800 participants could be achieved.

Data analysis will be conducted using the statistical software package JMP version 11.2 for Windows (SAS Institute Inc., Cary, NC, USA). A p value of =0.05 will be considered to be statistically significant.
Demographic data including age, gender, geographic location, job title, nursing history and previous exposure to kidney health related continuing professional development opportunities will be analysed using the chi-square test and independent t-tests. These tests will be used to examine the comparability of the two cohorts and determine whether there are any significant differences in their demographic characteristics and/or pre-test knowledge scores (Merrill, 2013).
Primary Hypothesis: Effectiveness of the intervention on the primary outcome within 1 week follow-up assessed by comparing those who receive the intervention against the active control group. The analysis will be done using Analysis of Covariance (ANCOVA). The treatment group and baseline value of the outcome will be included in the model as covariates. The intervention will be considered statistically significantly better than control if the p-value for the treatment group comparison is <0.05. An intention-to-treat analysis will be performed by including all available data from all participants randomised into the study.
Secondary hypothesis: The relationship between behavioural intent and the theoretical constructs of the Theory of Planned Behaviour (attitude, subjective norm and perceived behavioural control) will be assessed through linear regression. The outcome in the model will be behavioural intent, and independent variables will include treatment arm, the constructs of the Theory of Planned Behaviour. Potentially confounding variables such as age, years of experience and rurality will also be included in the model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/11/2017
Actual
9/11/2017
Date of last participant enrolment
Anticipated
29/06/2018
Actual
18/04/2018
Date of last data collection
Anticipated
3/08/2018
Actual
24/04/2018
Sample size
Target
280
Accrual to date
Final
430
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297538 0
University
Name [1] 297538 0
University of Newcastle
Country [1] 297538 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
Faculty of Health & Medicine
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 296546 0
None
Name [1] 296546 0
Address [1] 296546 0
Country [1] 296546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298634 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 298634 0
Ethics committee country [1] 298634 0
Australia
Date submitted for ethics approval [1] 298634 0
Approval date [1] 298634 0
14/11/2016
Ethics approval number [1] 298634 0
H-2016-0394

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2059 2059 0 0
/AnzctrAttachments/373665-HREC Expedited Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 77718 0
A/Prof Ashley Kable
Address 77718 0
University of Newcastle
School of Nursing & Midwifery
Faculty of Health & Medicine
University Drive
Callaghan NSW 2308
Country 77718 0
Australia
Phone 77718 0
+61 2 4921 6334
Fax 77718 0
Email 77718 0
[email protected]
Contact person for public queries
Name 77719 0
Peter Sinclair
Address 77719 0
University of Newcastle
School of Nursing & Midwifery
Faculty of Health & Medicine
University Drive
Callaghan NSW 2308
Country 77719 0
Australia
Phone 77719 0
+61 2 4921 7436
Fax 77719 0
Email 77719 0
[email protected]
Contact person for scientific queries
Name 77720 0
Peter Sinclair
Address 77720 0
University of Newcastle
School of Nursing & Midwifery
Faculty of Health & Medicine
University Drive
Callaghan NSW 2308
Country 77720 0
Australia
Phone 77720 0
+61 2 4921 7436
Fax 77720 0
Email 77720 0
[email protected]

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


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.