Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001730897
Ethics application status
Approved
Date submitted
16/11/2021
Date registered
20/12/2021
Date last updated
24/05/2022
Date data sharing statement initially provided
20/12/2021
Date results information initially provided
24/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of self-monitoring urate concentrations on adherence to allopurinol in people with gout
Scientific title
The effect of self-monitoring urate concentrations on adherence to allopurinol in people with gout
Secondary ID [1] 305802 0
None
Universal Trial Number (UTN)
Trial acronym
GPOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 324310 0
Condition category
Condition code
Musculoskeletal 321800 321800 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-monitoring urate using a point of care device
Brief Name. Point-of-care urate meter

Materials. The Medication Events Monitoring System (MEMS) Pill Cap, HumaSens2.0plus, uric acid testing strips, uric acid control solution, lancets and lancet pen.

Procedures. All participants will be provided with a point-of-care urate monitoring device, the HumaSens2.0plus for self-monitoring. Counselling on the correct use of the meter will be provided at the baseline visit by a study investigator. A 7-minute instructional video will be provided to assist in communicating the optimal operation technique. The manufacturer’s instructional booklet for the Humasens2.0plus will also be provided. Other informational resources are not provided. Information on interpreting the urate concentrations obtained from the device is also provided at baseline. Participants will then be asked to monitor their urate concentrations at least every month and during a gout flare. MEMS will be used to electronic monitor daily adherence to allopurinol. Follow-up visits at 1,2,3,4,5,6,9, and 12 months will occur. Feedback on their urate concentration will be provided. Information previously provided at baseline may be provided again at these follow-ups. Participants will continue their prescribed regime of allopurinol. Allopurinol prescriptions are at the discretion of the participants healthcare professional and will not be altered by study investigators.

Self-monitoring technique. Perform hand hygiene and gather equipment. Replace lancet in lancet pen. Insert uric acid test strip into Humasens2.0plus. Lancet fingertip and massage until a drop of blood forms. Wipe the drop of blood away using a clean tissue. Massage to produce second drop. Deposit second drop into sampling well on the uric acid test strip. Results of the reading should be returned shortly.

Delivery Site. This intervention will be delivered remotely. Investigators will follow-up and provide support via phone or video conferencing.

Intervention provider.
This study will be conducted remotely via internet video conferencing. Materials are dispatched via parcel post. Patients will interact with study investigators remotely as well.

Intervention delivery schedule. The intervention will be delivered throughout the 12-month observational period. Follow-up meetings with investigators are scheduled monthly for the first 6 months and every 3 months thereafter. The baseline visit will be conducted over video conferencing software (Zoom preferred). Follow-ups will be provided over video conferencing or phone calls. A session for administering a survey is scheduled for week 10. The baseline session is anticipated to be 1-hour in duration and all other follow-ups are expected to be 15-minutes each. Participants can contact investigators in the event of a gout flare, adverse event, and regarding technical issues.

Tailoring. Participants will be instructed to report their urate readings via SMS instantly. Feedback will be provided in the form of a visual chart delivered via SMS. Unacceptable urate concentrations will prompt intervention from the study rheumatologist.

Adherence/Fidelity Monitoring: Monitoring of adherence to the protocol is not planned. Any sub-optimal adherence to the intervention will reflect real-world conditions.
Intervention code [1] 322197 0
Treatment: Devices
Intervention code [2] 322379 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329561 0
Adherence to allopurinol as measured by electronic monitoring using MEMS.
Timepoint [1] 329561 0
Medication adherence is measured daily for 12-months post intervention commencement.
Secondary outcome [1] 402993 0
Urate concentrations (mmol/L) as measured by self-monitoring device, the Humasens2.0plus. Target attainment will be derived as proportion of time, urate-time curve is under or equal to target (0.36mmol/L).
Timepoint [1] 402993 0
Urate will be measured at least once a month for the 12-month duration of the study.
Secondary outcome [2] 402994 0
Incidence of self-reported gout flares. The flare will be assessed according to the clinical judgement of investigators taking into account pain level, duration, and any prophylactic therapy taken (i.e. corticosteroids, colchicine, NSAIDS) as reported by the participant.
Timepoint [2] 402994 0
Participants will monitor for gout flares for the duration of the 12-months observation period.
Secondary outcome [3] 402995 0
Consumer opinions regarding MEMS Mobile App as measured by a 16 item questionnaire. This will be administered electronically via Redcap. This questionnaire is provided by AARDEX group and specifically designed to capture opinions about the MEMS Mobile App.
Timepoint [3] 402995 0
One-month after commencing the study.
Secondary outcome [4] 402996 0
Health related quality of life as measured by the EQ5D5L. This will be administered electronically via Redcap.
Timepoint [4] 402996 0
When self-reported gout flares occur, 3-months, 6 months, 9 months, and 12-months after commencing the study.
Secondary outcome [5] 402997 0
Healthcare resource utilisation as measured by Medicare and PBS data, supplemented with a Mypan modified to suit gout.
Timepoint [5] 402997 0
Medicare and PBS data will be extracted for the for the 12-month study period and 12-months prior to study commencement to provide a baseline. Mypan data will be collected at 0, 4, 10, 16, 24, 26, 52 weeks after commencement.
Secondary outcome [6] 402998 0
Opinions on self-monitoring intervention via semi-structured interview. The questions were developed by the study team specifically for this study. This will be expected to take 30 minutes. It will be audiotaped and transcribed verbatim.
Timepoint [6] 402998 0
At 12 months post-intervention commencement.
Secondary outcome [7] 402999 0
Self-reported device (Humasens2.0plus) related adverse events documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0).
Timepoint [7] 402999 0
Participants will monitor for device related adverse events for the duration of the 12-months observation period.

Eligibility
Key inclusion criteria
At least 18 years old.
Proficient in English.
Lives in the jurisdiction of Australia
Has self-reported gout
Is on allopurinol therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uses a weekly medication planner e.g. a Webster pack
Has a caregiver involved in medication taking.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Only an exploratory analysis is planned as this a pilot trial.

Adherence Data from the MEMS bottle will be downloaded and processed (CSS v. 2.1; Aardex) to analyse dosing histories. If necessary, days of special openings of the pill bottle (such as pharmacy visits) will not be used in the analyses.
Patient adherence will be calculated as taking compliance (the percentage of prescribed doses taken) and correct dosing (only relevant for twice daily dosing) which is the percentage of days on which the correct number of doses
was taken. Taking compliance will be calculated as total number of openings/total number of prescribed doses ×100%. Correct dosing will be calculated as total number of days with openings as prescribed/total number of monitored days) × 100%. Adherence data obtained from the present study will be compared to measures of adherence obtained previously in a retrospective study evaluating the dispensing history
for allopurinol in Australia from 2015 to 2019 using a 10% PBS dataset. For each participant the relationship between urate concentrations and allopurinol dose or adherence will be assessed.

Interviews will be audiotaped and transcribed verbatim. Non-identifiable transcripts will be reviewed and analysed to identify themes. Investigators will meet periodically throughout data collection to discuss interview responses and themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2022
Actual
19/01/2022
Date of last participant enrolment
Anticipated
1/02/2022
Actual
18/03/2022
Date of last data collection
Anticipated
1/02/2023
Actual
23/05/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310154 0
Charities/Societies/Foundations
Name [1] 310154 0
Arthritis Australia
Country [1] 310154 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 311231 0
None
Name [1] 311231 0
Address [1] 311231 0
Country [1] 311231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309843 0
University of Sydney Human Ethics
Ethics committee address [1] 309843 0
Level 3, Michael Spence Building (F23)
University of Sydney Camperdown NSW 2006
Ethics committee country [1] 309843 0
Australia
Date submitted for ethics approval [1] 309843 0
Approval date [1] 309843 0
05/05/2021
Ethics approval number [1] 309843 0
2021/216

Summary
Brief summary
Gout has effective, safe and readily available therapies. Yet it continues to be sub-optimally managed in the community. This is due to poor adherence to medication taking. We want to examine the relationship between self-monitoring of urate and urate-lowering medication taking behaviour.

We hypothesise that self-monitoring of urate concentrations enhances adherence to urate-lowering medicines. That is, patient measuring their urate and seeing the results will encourage them to take medications as prescribed.

We are conducting a proof-of-concept study with 30 people with gout. They are provided with the point-of-care uric acid monitoring meter, the HumaSens2.0plus, for self-monitoring throughout the year. Adherence to medication (MEMS), gout flare occurrence, and urate will monitor throughout the year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115578 0
Dr Sophie Stocker
Address 115578 0
Rm No S303, Building No A15, The University of Sydney, Camperdown, NSW 2006
Country 115578 0
Australia
Phone 115578 0
+61 2 9114 4756
Fax 115578 0
+61 2 9351 4791
Email 115578 0
sophie.stocker@sydney.edu.au
Contact person for public queries
Name 115579 0
Dr Sophie Stocker
Address 115579 0
Rm No S303, Building No A15, The University of Sydney, Camperdown, NSW 2006
Country 115579 0
Australia
Phone 115579 0
+61 2 9114 4756
Fax 115579 0
+61 2 9351 4791
Email 115579 0
sophie.stocker@sydney.edu.au
Contact person for scientific queries
Name 115580 0
Dr Sophie Stocker
Address 115580 0
Rm No S303, Building No A15, The University of Sydney, Camperdown, NSW 2006
Country 115580 0
Australia
Phone 115580 0
+61 2 9114 4756
Fax 115580 0
+61 2 9351 4791
Email 115580 0
sophie.stocker@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD data will not be made available in accordance with our ethics approval.


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.