Application for Monitoring and Evaluation of Raynaud's Phenomenon

Raynaud Phenomenon Clinical Trial

— RaynaudMoni  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984422
• Other study ID #: 38RC19.099
• Secondary ID: 2019-A00987-50
• Status: Recruiting
• Start date: March 31, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Grenoble
• Contact: Matthieu Roustit, PharmD, PhD
• Phone: +33476767856
• Email: mroustit[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon

Intervention

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

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

Denton 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. — View Citation

Fava 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. — View Citation

Herrick 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. — View Citation

Maricq 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. — View Citation

Roustit 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. — View Citation

Seibold 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Effect of Raynaud etiology on thermographic data	Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud	2 weeks
Secondary	Effect of Raynaud treatment on thermographic data	Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients	2 weeks