gout
Conditions
Interventions
Intervention for Patient Participants:
An overview of the intervention and procedures can be seen in Table 1 of the
protocol. Patients wishing to participate (see section 12.2 for the consent
proce
Sponsors
Sint Maartenskliniek
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients: In order to be eligible to participate in this study, a patient subject must meet all of the following criteria: • Have a clinical diagnosis of gout • Are older than 16 years of age • Not at sUA target of 0.36 mmol/L (or 0.30 for tophaceous gout, chronic arthropathy and frequent attacks), based on lab results not older than 6 weeks. • Starting ULT (allopurinol, benzbromarone, febuxostat, probenecid or pegloticase) or using ULT but not at sUA target • Able and willing to sign informed consent • Possession of a digital device (e.g. smartphone, laptop, tablet), email address and in-ternet connection • Willing to use a POCT at home • Sufficient understanding of the Dutch language Stakeholders: In order to be eligible for the stakeholder interviews, a stakeholder must have been involved in involved in carrying out, or managing the current study.
Exclusion criteria
Exclusion criteria: Patients who have contra indications for using urate-lowering therapry (ULT) and not being able to measure sUA at home. Patients with mild kidney disease (CKD-EPI between 0.45 and 0.90 ml/min/1.73m2) can be included but patients with severe kidney disease (CKD-EPI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome to answer the primary research question is patient and stakeholder feasibility of sUA home monitoring and nurse-led T2T, which will be assessed on the following domains: Acceptability (How individuals involved react to the program): Patient acceptability of the POCT-device itself and sUA home monitoring and nurse-led T2T as a whole will be studied according to the Technology Acceptance Model (TAM) using questions included in both the 12 week and 24 week questionnaire. Ease of use of the POCT device will be assessed by the system usability scale (SUS, Dutch version), in which 10 questions are asked on a 5-point Likert scale (Appendix 1, Part 1, Question 1-10). Perceived usefulness of sUA home monitoring and nurse-led T2T will be assessed by 9 questions on a 5-point likert scale (Appendix 1, Part 2, Question 1 - 9). Attitude towards using and intention to use the POCT device itself will be assessed by 5 questions relating to the overall satisfaction with and rating of the device, and intention to use the device in the future (Appendix 1, Part 2, question 10 - 15). Furthermore, acceptability of the POCT-device is evaluated by two ques-tions related to attractiveness and appropriateness of the POCT-device (Appendix 1, Part 1, Question 11 - 12), and the physical and mental burden of home monitoring sUA (Appendix 1, Part 3, Question 5 - 8). Stakeholders* acceptability for sUA home monitoring and nurse-led T2T will be evaluated through semi-structured interviews (Appendix 2) and weekly journal entries describing their barriers/facilitators and other remarks. Demand (Use and/or need for the intervention): Patients* demand for sUA home monitoring and nurse-led T2T will be assessed by two ques-tionnaire items related to actual use of the POCT-device (Appendix 1, Part 2, Question 16 -17), included in both the 12 week and 24 week questionnaire. Additionally, the adherence to the communication of sUA measurements towards the hospital i | — |
Countries
Netherlands
Outcome results
None listed