Clinical trial NCT03984422: Application for Monitoring and Evaluation of Raynaud's Phenomenon
Official title: Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Raynaud Phenomenon
Keywords: smartphone application
monitoring
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected in conjunction with a scheduled consultation in the Vascular Medicine Department or at the Clinical Research Center

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


Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon
timeFrame: 2 weeks
Secondary outcomes:
measure: Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon
timeFrame: 2 weeks
measure: Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks
timeFrame: 2 weeks
measure: Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks
timeFrame: 2 weeks
measure: Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks
timeFrame: 2 weeks
measure: Effect of Raynaud etiology on thermographic data
timeFrame: 2 weeks
measure: Effect of Raynaud treatment on thermographic data
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
state: Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Matthieu Roustit, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.