The effect of self-monitoring urate concentrations on adherence to allopurinol in people with gout

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.