Application for Monitoring and Evaluation of Raynaud's Phenomenon
RaynaudMoni
Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
2 other identifiers
observational
120
1 country
1
Brief Summary
To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedDecember 6, 2023
December 1, 2023
12 months
May 24, 2019
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks
2 weeks
Effect of Raynaud etiology on thermographic data
2 weeks
- +1 more secondary outcomes
Study Arms (1)
Raynaud phenomenon
Use of smartphone application
Interventions
use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.
Eligibility Criteria
Patients will be selected in conjunction with a scheduled consultation in the Vascular Medicine Department or at the Clinical Research Center
You may qualify if:
- 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
You may not qualify if:
- Subject under administrative or judicial supervision
- Subject not speaking and not understanding French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Grenoble Alpes
Grenoble, Grenoble, 38043, France
Related Publications (7)
Wigley FM, Flavahan NA. Raynaud's Phenomenon. N Engl J Med. 2016 Aug 11;375(6):556-65. doi: 10.1056/NEJMra1507638. No abstract available.
PMID: 27509103BACKGROUNDHerrick AL. The pathogenesis, diagnosis and treatment of Raynaud phenomenon. Nat Rev Rheumatol. 2012 Aug;8(8):469-79. doi: 10.1038/nrrheum.2012.96. Epub 2012 Jul 10.
PMID: 22782008BACKGROUNDSeibold JR, Wigley FM. Editorial: Clinical Trials in Raynaud's Phenomenon: A Spoonful of Sugar (Pill) Makes the Medicine Go Down (in Flames). Arthritis Rheumatol. 2017 Dec;69(12):2256-2258. doi: 10.1002/art.40307. Epub 2017 Nov 10. No abstract available.
PMID: 28859256BACKGROUNDRoustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.
PMID: 30383134BACKGROUNDFava A, Wung PK, Wigley FM, Hummers LK, Daya NR, Ghazarian SR, Boin F. Efficacy of Rho kinase inhibitor fasudil in secondary Raynaud's phenomenon. Arthritis Care Res (Hoboken). 2012 Jun;64(6):925-9. doi: 10.1002/acr.21622. Epub 2012 Jan 24.
PMID: 22275160BACKGROUNDDenton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.
PMID: 29193819BACKGROUNDMaricq HR, Carpentier PH, Weinrich MC, Keil JE, Franco A, Drouet P, Poncot OC, Maines MV. Geographic variation in the prevalence of Raynaud's phenomenon: Charleston, SC, USA, vs Tarentaise, Savoie, France. J Rheumatol. 1993 Jan;20(1):70-6.
PMID: 8441170BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthieu Roustit, PharmD, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
June 13, 2019
Study Start
March 31, 2020
Primary Completion
March 30, 2021
Study Completion
June 30, 2024
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share