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Application for Monitoring and Evaluation of Raynaud's Phenomenon

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03984422
Acronym
RaynaudMoni
Enrollment
120
Registered
2019-06-13
Start date
2020-03-31
Completion date
2024-06-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud Phenomenon

Keywords

smartphone application, monitoring

Brief summary

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

Interventions

OTHERSmartphone application

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon2 weeksThe 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

MeasureTime frameDescription
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks2 weeksCorrelation between digital temperature and the daily frequency of attacks
Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks2 weeksCorrelation between digital temperature and the cumulative daily duration of attacks
Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon2 weeksCorrelation between digital temperature and Raynaud's Condition Score (RCS)
Effect of Raynaud etiology on thermographic data2 weeksComparison of cutaneous digital temperature between patients with primary and secondary Raynaud
Effect of Raynaud treatment on thermographic data2 weeksComparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients
Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks2 weeksCorrelation between digital temperature and pain during attacks (assessed through a 10-point VAS)

Countries

France

Contacts

Primary ContactMatthieu Roustit, PharmD, PhD
mroustit@chu-grenoble.fr+33476767856
Backup ContactAdeline PARIS, PharmD, PhD
aparis@chu-grenoble.fr+33476767383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026