Application for Monitoring and Evaluation of Raynaud's Phenomenon

N/AUnknownNCT03984422

University Hospital, Grenoble120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Raynaud Phenomenon

Interventions

Smartphone applicationOTHER

use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Chu Grenoble Alpes

Grenoble, Grenoble, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 2 weeks

Effect of Raynaud etiology on thermographic data

Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud

Time frame: 2 weeks

Effect of Raynaud treatment on thermographic data

Central Contacts

Matthieu Roustit, PharmD, PhD

CONTACT

+33476767856 mroustit@chu-grenoble.fr

Adeline PARIS, PharmD, PhD

CONTACT

+33476767383 aparis@chu-grenoble.fr

Data from ClinicalTrials.gov

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