Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000108314
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
21/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Making information about gout and its treatment more understandable to patients with gout
Scientific title
Does personalisation make a difference: the effect of personalised visualisation of gout on illness perceptions and medication beliefs in patients with tophaceous gout
Secondary ID [1] 290953 0
None
Universal Trial Number (UTN)
U1111-1190-9098
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 301689 0
Condition category
Condition code
Public Health 301396 301396 0 0
Health promotion/education
Inflammatory and Immune System 301410 301410 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: The effect of personalised visualisation of information about gout on illness perceptions and medications beliefs in patients with gout.

Patients diagnosed with tophaceous gout, who already participated in other studies and expressed an interest in future studies will be contacted via a phone call or email by a co-ordinating investigator (CI). They will be informed about the study and invited to participate. If they express interest, the co-ordinating investigator (PhD in Health Psychology candidate) will forward them a participant information sheet and a consent form.
Participants’ medical records concerning their diagnosis of gout will be reviewed by the CI to identify participants who have undergone computed tomography for gout in the past two years. Individuals with recent CT scans will be randomised either to the personalised or non-personalised visualisation group. Individuals who do not have recent CT scans for gout will be allocated to the control group. Participants will not know which group they were allocated to. Individuals who met the eligibility criteria and agreed to participate in the study will be invited to attend a single 30-40 minute session at the Clinical Research Centre at Auckland Medical School.
At the lab, having signed the consent form, participants will be offered to complete a set of baseline assessment questionnaires followed by a 12-minute educational presentation. The questionnaires will ask about a range of questions about participants’ attitudes towards gout, its treatment, and demographic information.
The presentation will be targeting medication non-adherence and include recommendations from the New Zealand Ministry of Health, as well as information and images from “To Stop Gout You Need to Bring Your Uric Acid Levels Down” booklet that is available online at the New Zealand Ministry of Health website.
Participants in the control group will see only this presentation and get verbal information about how computed tomography could be used for gout diagnosing and monitoring, but they will not see any examples of CT scans.
Individuals in the non-personalised visualisation group will see the same presentation and generic CT scans showing gout. The co-ordinating investigator will also explain how CT scans are used in gout monitoring and show generic CT scans for gout.
Participants in the personalised visualisation group will see the same presentation with their own CT scans incorporated in it. The co-ordinating investigator will explain how CT scans are used in gout monitoring and show patients their own scans stressing the point that the scans they see are their own CT results.
The intervention will be based on a PowerPoint presentation delivered on a laptop as well as verbal information about gout, its diagnosis and treatment. The co-ordinating investigator (the PhD in Health Psychology candidate) will follow a memorised script accompanied with images explaining gout and the medication for gout incorporated into a PowerPoint presentation. Patients under all conditions will receive equal amount of textual and verbal information.
Right after the intervention all participants will be asked to complete the second assessment, provide feedback and ask any questions they might have about the study.
Intervention code [1] 296901 0
Behaviour
Intervention code [2] 296902 0
Lifestyle
Intervention code [3] 296918 0
Treatment: Other
Comparator / control treatment
Individuals who do not have recent CT scans for gout will be allocated to the control group. Participants in the control group will see a 12-minute educational presentation, and get verbal information about how computed tomography could be used for gout diagnosing and monitoring. The presentation will be targeting medication non-adherence and include recommendations from the New Zealand Ministry of Health, as well as information and images from “To Stop Gout You Need to Bring Your Uric Acid Levels Down” booklet that is available online at the New Zealand Ministry of Health website.
Control group
Active

Outcomes
Primary outcome [1] 300790 0
Changes in patients' illness perceptions assessed with The Brief Illness Perceptions Questionnaire (Broadbent, Petrie, Main & Weinman, 2006)
Timepoint [1] 300790 0
Immediately after the intervention
Primary outcome [2] 300791 0
Change in medication beliefs assessed with The beliefs about medication for gout questionnaire that was created for the purpose of this study and is based on the necessity-concerns framework (Horne, Weinman, & Hankins, 1999)
Timepoint [2] 300791 0
Immediately after the intervention
Secondary outcome [1] 330866 0
Intervention satisfaction assessed with the intervention feedback questionnaire developed for the purpose of this study
Timepoint [1] 330866 0
At the end of the single lab session

Eligibility
Key inclusion criteria
General inclusion criteria: adults aged 18 and over; are able to provide written informed consent; are able to speak English. Individuals suffering from tophaceous or non-tophaceous gout, who already participated in other studies and expressed interest in future research, will be eligible to take part in the study. Patients who have undergone computed tomography for gout within the previous six years will be eligible for inclusion in a personalised or non-personalised intervention group.
Patients who do not have CT scans will be included in the control group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
were not prescribed with urate-lowering medication; undergone computed tomography for gout more than six years ago; do not speak English well enough to participate; not able to provide written informed consent

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size (N=60) was calculated using GPower Software for ANOVA (repeated measures within-between interaction), assuming medium effect size (f=0.25), a= 0.05, power 0.80, r=0.3, non-sphericity correction e =1 for three groups and two measures.
Data will be analysed in IBM SPSS. We will use multiple ANOVA with repeated measures to test within-between group effects, post hoc ANOVA tests and correlation coefficients (Spearman or Pearson).





Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2017
Actual
29/05/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
30/03/2018
Date of last data collection
Anticipated
Actual
30/03/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8585 0
New Zealand
State/province [1] 8585 0

Funding & Sponsors
Funding source category [1] 295375 0
University
Name [1] 295375 0
The University of Auckland
Country [1] 295375 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 294197 0
None
Name [1] 294197 0
Address [1] 294197 0
Country [1] 294197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296708 0
Health and Disability Ethics Committees
Ethics committee address [1] 296708 0
Ethics committee country [1] 296708 0
New Zealand
Date submitted for ethics approval [1] 296708 0
11/01/2017
Approval date [1] 296708 0
02/05/2017
Ethics approval number [1] 296708 0
Ethics committee name [2] 299395 0
ADHB
Ethics committee address [2] 299395 0
Ethics committee country [2] 299395 0
New Zealand
Date submitted for ethics approval [2] 299395 0
13/03/2017
Approval date [2] 299395 0
09/05/2017
Ethics approval number [2] 299395 0
A+ 7522

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1383 1383 0 0
/AnzctrAttachments/372127-Personalisation study_PIS-CF.docx (Participant information/consent)

Contacts
Principal investigator
Name 71566 0
Ms Alina Krasnoryadtseva
Address 71566 0
Auckland Hospital
Bld 599, Level 12, Room 12.044
2 Park Road, Grafton, Auckland
1023
Department of Psychological Medicine
The University of Auckland
Country 71566 0
New Zealand
Phone 71566 0
+64210417277
Fax 71566 0
Email 71566 0
a.krasnoryadtseva@auckland.ac.nz
Contact person for public queries
Name 71567 0
Alina Krasnoryadtseva
Address 71567 0
Auckland Hospital
Bld 599, Level 12, Room 12.044
2 Park Road, Grafton, Auckland
1023
Department of Psychological Medicine
The University of Auckland
Country 71567 0
New Zealand
Phone 71567 0
+64210417277
Fax 71567 0
Email 71567 0
a.krasnoryadtseva@auckland.ac.nz
Contact person for scientific queries
Name 71568 0
Alina Krasnoryadtseva
Address 71568 0
Auckland Hospital
Bld 599, Level 12, Room 12.044
2 Park Road, Grafton, Auckland
1023
Department of Psychological Medicine
The University of Auckland
Country 71568 0
New Zealand
Phone 71568 0
+64210417277
Fax 71568 0
Email 71568 0
a.krasnoryadtseva@auckland.ac.nz

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.