Application for Monitoring and Evaluation of Raynaud's Phenomenon

Study Overview
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Brief Summary
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To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.

Official Title
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Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon

Conditions
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Raynaud Phenomenon

Intervention / Treatment
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* Other: Smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or secondary Raynaud phenomenon clinically diagnosed by a physician Phone compatible with the application (most Android smartphones) Non-opposition of participation in the study Affiliation to the social security scheme or beneficiary of such a scheme Exclusion Criteria: Subject under administrative or judicial supervision Subject not speaking and not understanding French

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Raynaud phenomenon<br>Use of smartphone application | Other: Smartphone application<br>* use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon | The questionnaire assesses different items such as the ease of use of the application, the installation process on the smartphone, the use of reminders, etc. Overall satisfaction will be calculated as the non-weighted average of all items. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon | Correlation between digital temperature and Raynaud's Condition Score (RCS) | 2 weeks | 
| Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks | Correlation between digital temperature and the daily frequency of attacks | 2 weeks | 
| Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks | Correlation between digital temperature and the cumulative daily duration of attacks | 2 weeks | 
| Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks | Correlation between digital temperature and pain during attacks (assessed through a 10-point VAS) | 2 weeks | 
| Effect of Raynaud etiology on thermographic data | Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud | 2 weeks | 
| Effect of Raynaud treatment on thermographic data | Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartphone application, monitoring