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Trial registered on ANZCTR


Registration number
ACTRN12616001443482
Ethics application status
Approved
Date submitted
29/09/2016
Date registered
14/10/2016
Date last updated
24/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness of point-of-care touchscreen computer assessment and printed feedback for improving self-management of health risks among general practice patients
Scientific title
Testing the effectiveness of point-of-care touchscreen computer assessment and printed feedback for improving self-management of health risks among general practice patients
Secondary ID [1] 289900 0
None
Universal Trial Number (UTN)
U1111-1185-7799
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 299661 0
colorectal cancer 299659 0
breast cancer 299660 0
depression 299662 0
Condition category
Condition code
Cancer 300370 300370 0 0
Bowel - Anal
Public Health 299605 299605 0 0
Health promotion/education
Cancer 300371 300371 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible general practice patients will complete a brief (approximately 5 to 10 minutes) touchscreen computer survey on a tablet device while in the waiting room prior to their appointment. The survey will assess the patient's potential health risks related to under-screening for bowel cancer, cervical (women only) and breast cancer (women only), smoking, risky alcohol consumption and depression. For intervention participants, preferences for help with identified health risks will be elicited as part of the survey. Upon completion of the survey, intervention participants will receive printed feedback on health risks identified from their survey along with recommended self-management actions as endorsed by a range of Australian Government-supported organisations aimed at promoting health in these areas. Participants who report being under-screened for cancer (bowel, breast, cervical) will be encouraged to discuss screening options with their doctor. Participants identified as smokers will be presented with self-management options such as referral to Quitline (a telephone-based smoking cessation intervention), talking to their doctor, and nicotine replacement therapy etc. Participants identified as drinking above recommended levels will be presented with options for reducing alcohol intake such as choosing alcoholic drinks with lower alcohol content, and discussing approaches with their doctor etc. Participants who report depressed mood will be presented with options such as attending counselling, contacting Beyondblue (a telephone-based emotional support service), and discussing with their GP etc. The printed feedback will be given to patients in an envelope by a research assistant immediately after completion of the baseline survey in the primary care clinic. This feedback will be tailored to reflect the patient's identified health risks as assessed by the survey. The research assistant will not provide any medical advice on identified health risks or self-management actions.
Intervention code [1] 295584 0
Prevention
Intervention code [2] 295583 0
Early detection / Screening
Intervention code [3] 295585 0
Lifestyle
Comparator / control treatment
Participants in the control condition will not receive information about their identified health risks or self-management strategies. The survey will not elicit preferences for help for control participants. Control participants will not receive printed feedback on their baseline survey results. As an exception, control participants who score 15 or more on the PHQ-9 depression assessment will receive onscreen advise to discuss with their doctor. The contact details for Beyondblue will also be provided.


Control group
Active

Outcomes
Primary outcome [1] 299234 0
The primary outcome will be the proportion of patients within each group who report undertaking one or more self-management actions in relation to health risk factors identified at baseline. Self management actions will be elicited by a survey specifically designed for this study.
Timepoint [1] 299234 0
1-month follow-up.
Secondary outcome [1] 328079 0
A secondary aim will be to explore the impact of depression at baseline on self management behaviours at one month follow up. The PHQ-9 will be used to assess depression and an instrument designed for this study will be used to assess self management behaviours.
Timepoint [1] 328079 0
1 month follow up

Eligibility
Key inclusion criteria
Patients aged at least 18 years of age who are presenting to the general practitioner for an appointment, English speaking, who are able to provide informed consent and have at least one health risk factor identified at baseline.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients less than 18 years old. Patients who are considered too unwell to participate by practice staff. Patients that are unable to complete the touchscreen survey on their own (e.g. vision-impaired, non-English speaking).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Separate computer-generated randomisation tables will be generated for each clinic. Each day that recruitment takes place in a participating clinic will be randomly allocated to either the intervention or control condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Consent bias. The age and sex of consenters and non-consenters will be compared using the chi square test for categorical variables and the t-test or non-parametric equivalent for continuous variables. Descriptive statistics including frequencies, proportions, 95% confidence intervals and means will be calculated to describe risk factor status and demographic characteristics of the sample. The proportion of participants in each group who report one or more self-management action at follow up will be calculated. A logistic regression, with group allocation as the main predictor of interest, will be used to assess the impact of the intervention on preventive care actions. Parameters will be estimated under a generalised estimating equation (GEE) framework to allow for potential clustering of patients from the same day. Other potentially confounding demographic and clinical variables will be adjusted for in the regression model in a secondary analysis (these will be pre-specified in a statistical analysis plan). A total sample of 360 participants will be recruited at baseline (180 per group). Allowing for 15% attrition at one month follow up this will give an effective sample of 150 per group. Assuming a recruitment rate of 7 patients per day and allowing an icc of 0.01 for patients from the same day, a sample of this size, recruited over 42 days (of which 21 are intervention days) will give 80% power to detect a 15% increase in the proportion of patients who report one or more self-management actions at the 5% significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2016
Actual
21/10/2016
Date of last participant enrolment
Anticipated
Actual
2/11/2017
Date of last data collection
Anticipated
Actual
5/12/2017
Sample size
Target
360
Accrual to date
Final
370
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294269 0
Charities/Societies/Foundations
Name [1] 294269 0
Cancer Institute NSW
Country [1] 294269 0
Australia
Funding source category [2] 294268 0
Government body
Name [2] 294268 0
National Health and Medical Research Council (NHMRC)
Country [2] 294268 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan
NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 293104 0
None
Name [1] 293104 0
Address [1] 293104 0
Country [1] 293104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295696 0
University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 295696 0
Ethics committee country [1] 295696 0
Australia
Date submitted for ethics approval [1] 295696 0
20/04/2016
Approval date [1] 295696 0
05/07/2016
Ethics approval number [1] 295696 0
H-2016-0141

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

Contacts
Principal investigator
Name 67778 0
Dr Mariko Carey
Address 67778 0
Health Behaviour Research Group
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308, Australia
Country 67778 0
Australia
Phone 67778 0
+61 2 4042 0702
Fax 67778 0
Email 67778 0
mariko.carey@newcastle.edu.au
Contact person for public queries
Name 67779 0
Mariko Carey
Address 67779 0
Health Behaviour Research Group
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308, Australia
Country 67779 0
Australia
Phone 67779 0
+61 2 4042 0702
Fax 67779 0
Email 67779 0
mariko.carey@newcastle.edu.au
Contact person for scientific queries
Name 67780 0
Mariko Carey
Address 67780 0
Health Behaviour Research Group
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308, Australia
Country 67780 0
Australia
Phone 67780 0
+61 2 4042 0702
Fax 67780 0
Email 67780 0
mariko.carey@newcastle.edu.au

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.