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

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ClinicalTrials.gov Identifier: NCT03984422
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

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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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 2, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984422


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

Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Matthieu Roustit, PharmD, PhD University Hospital, Grenoble

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03984422     History of Changes
Other Study ID Numbers: 38RC19.099
2019-A00987-50 ( Other Identifier: ID RCB )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
smartphone application
monitoring

Additional relevant MeSH terms:
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Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases