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出境医 / 临床实验 / Application for Monitoring and Evaluation of Raynaud's Phenomenon (RaynaudMoni)

Application for Monitoring and Evaluation of Raynaud's Phenomenon (RaynaudMoni)

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

Condition or disease Intervention/treatment
Raynaud Phenomenon Other: Smartphone application

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Raynaud phenomenon
Use of smartphone application
 Other: Smartphone application
use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.
Outcome Measures
Primary Outcome Measures :
  1. Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon [ Time Frame: 2 weeks ]
    Correlation between digital temperature and Raynaud's Condition Score (RCS)

  2. Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and the daily frequency of attacks

  3. Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and the cumulative daily duration of attacks

  4. Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and pain during attacks (assessed through a 10-point VAS)

  5. Effect of Raynaud etiology on thermographic data [ Time Frame: 2 weeks ]
    Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud

  6. Effect of Raynaud treatment on thermographic data [ Time Frame: 2 weeks ]
    Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Contacts
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Contact: Matthieu Roustit, PharmD, PhD +33476767856 mroustit@chu-grenoble.fr
Contact: Adeline PARIS, PharmD, PhD +33476767383 aparis@chu-grenoble.fr

Locations
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France
Chu Grenoble Alpes Recruiting
Grenoble Cedex 9, Grenoble, France, 38043
Contact: Matthieu Roustit       mroustit@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Matthieu Roustit, PharmD, PhD University Hospital, Grenoble
Tracking Information
First Submitted Date May 24, 2019
First Posted Date June 13, 2019
Last Update Posted Date September 1, 2020
Actual Study Start Date March 31, 2020
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019) 		Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon [ Time Frame: 2 weeks ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
  • Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon [ Time Frame: 2 weeks ]
    Correlation between digital temperature and Raynaud's Condition Score (RCS)
  • Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and the daily frequency of attacks
  • Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and the cumulative daily duration of attacks
  • Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks [ Time Frame: 2 weeks ]
    Correlation between digital temperature and pain during attacks (assessed through a 10-point VAS)
  • Effect of Raynaud etiology on thermographic data [ Time Frame: 2 weeks ]
    Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud
  • Effect of Raynaud treatment on thermographic data [ Time Frame: 2 weeks ]
    Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Application for Monitoring and Evaluation of Raynaud's Phenomenon
Official Title Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
Brief Summary To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition 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.
Study Groups/Cohorts Raynaud phenomenon
Use of smartphone application
Intervention: Other: Smartphone application
Publications *
  • Wigley FM, Flavahan NA. Raynaud's Phenomenon. N Engl J Med. 2016 Aug 11;375(6):556-65. doi: 10.1056/NEJMra1507638. Review.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • Denton CP, Hachulla É, 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.
  • Maricq HR, Carpentier PH, Weinrich MC, Keil JE, Franco A, Drouet P, Ponçot 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2019) 		120
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Matthieu Roustit, PharmD, PhD +33476767856 mroustit@chu-grenoble.fr
Contact: Adeline PARIS, PharmD, PhD +33476767383 aparis@chu-grenoble.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03984422
Other Study ID Numbers 38RC19.099
2019-A00987-50 ( Other Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Matthieu Roustit, PharmD, PhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date August 2020

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