Application for Monitoring and Evaluation of Raynaud's Phenomenon

Recruiting

• Conditions: Raynaud Phenomenon
• Interventions: Other: Smartphone application

• Registration Number: NCT03984422
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Study Start: 2020-03-31
• Primary Completion: 2021-03-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Raynaud phenomenon	Smartphone application	Use of smartphone application

Primary Outcome Measures

Name	Time	Method
Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon	2 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, Grenoble, France