Real-time monitoring the occurrence of gout flares in patients by incorporation of the 2017 gout flare definition into an eHealth platform: a feasibility study.
Completed
- Conditions
- gout1003754610023213
- Registration Number
- NL-OMON45981
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Patients aged *18 years
- A diagnosis of crystal proven gout or a high clinical suspicion of gout
- At least one (possible) flare reported in the last three months
- Possession of an Android or iOS-based smartphone or tablet
Exclusion Criteria
- Stable gout with no flares over the last year
- Life expectancy less than 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter will be the score provided by the System Usability<br /><br>Scale (SUS) [Brooke J. Usability Evaluation in Industry 1996] as a measure for<br /><br>*perceived ease of use*. The SUS is a ten item questionnaire with five response<br /><br>options, generating a score between zero and forty. This score is multiplied<br /><br>two and a half times to adjust the score to a zero and one hundred point score.<br /><br>Finally, this score is categorised in concordance with Bangor et al:<br /><br>Score = >80 Continue research on Q1.6 gout app without adjustments<br /><br>Score = 50 * 80 Adjust Q1.6 gout app before continuing<br /><br>Score = <50 Abolish or redesign platform applying gout flare<br /><br>measurement<br /><br><br /><br>The other main parameter is the *perceived usefulness*. This is a descriptive<br /><br>measure and assessed using the translated and adapted version of the<br /><br>questionnaire by Davis Jr.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To be able to answer the secondary research questions, the following secondary<br /><br>study parameters will also be collected:<br /><br>- Number of gout flares reported by patients during three months<br /><br>- Proportion of gout flares reported by patients that last longer than three<br /><br>consecutive days.<br /><br>- Uptake: number of patients that have been approached to commit to the<br /><br>feasibility study in order to reach thirty inclusions<br /><br>- Period of use: the time period that the subject actively uses the app<br /><br>- Application adherence: percentage of days that questions have been answered<br /><br>- All contact with the Q1.6 helpdesk of included subjects will be documented<br /><br>using a case report form</p><br>