Raynaud PhenomenonRaynaudMoniNCT03984422
Application for Monitoring and Evaluation of Raynaud's Phenomenon
An observational study of Raynaud Phenomenon, run by University Hospital, Grenoble at 1 site in France.
Trial summary
To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- Smartphone application
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected in conjunction with a scheduled consultation in the Vascular Medicine Department or at the Clinical Research Center
Who may be able to join
- 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
Who cannot join
- Subject under administrative or judicial supervision
- Subject not speaking and not understanding French
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, Grenoble, 38043
Matthieu Roustit, mroustit@chu-grenoble.fr
About this study
Official title: Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.
- Conditions
- Raynaud Phenomenon
- Being tested
- Smartphone application
- Keywords
- smartphone application, monitoring
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone applicationOther
use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.
| Study group | Role | What they receive |
|---|---|---|
| Raynaud phenomenon | Use of smartphone application Receives: Other: Smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (6)
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)
Measured: 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks
Correlation between digital temperature and the daily frequency of attacks
Measured: 2 weeks
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
Measured: 2 weeks
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)
Measured: 2 weeks
Effect of Raynaud etiology on thermographic data
Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud
Measured: 2 weeks
Effect of Raynaud treatment on thermographic data
Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start31 Mar 2020
- Primary completion30 Mar 2021
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Roustit, PharmD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984422
- Sponsor's protocol ID
- 38RC19.099
- Other IDs
- 2019-A00987-50
- Acronym
- RaynaudMoni
- Status last verified
- Dec 2023
- First submitted
- 24 May 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27509103Herrick 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.
PubMed 22782008Seibold 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.
PubMed 28859256Roustit 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.
PubMed 30383134Fava 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.
PubMed 22275160Denton 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.
PubMed 29193819Maricq 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.
PubMed 8441170
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT03984422
- Acronym / sponsor ID
- RaynaudMoni / 38RC19.099
- Conditions
- Raynaud Phenomenon
- Keywords
- smartphone application, monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raynaud phenomenon | – | Other: Smartphone applicationUse of smartphone application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected in conjunction with a scheduled consultation in the Vascular Medicine Department or at the Clinical Research Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subject under administrative or judicial supervision
- Subject not speaking and not understanding French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone applicationuse of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger. | Other | Raynaud phenomenon |
Primary outcome
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.
6 secondary outcomes
Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon
Time frame: 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks
Time frame: 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks
Time frame: 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks
Time frame: 2 weeks
Effect of Raynaud etiology on thermographic data
Time frame: 2 weeks
Effect of Raynaud treatment on thermographic data
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 27509103Wigley FM, Flavahan NA. Raynaud's Phenomenon. N Engl J Med. 2016 Aug 11;375(6):556-65. doi: 10.1056/NEJMra1507638. No abstract available.
- Background: PubMed 22782008Herrick 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.
- Background: PubMed 28859256Seibold 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.
- Background: PubMed 30383134Roustit 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.
- Background: PubMed 22275160Fava 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.
- Background: PubMed 29193819Denton 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.
- Background: PubMed 8441170Maricq 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.
- Individual participant dataSharing planned: No
Related trials for Raynaud Phenomenon
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Buerger Disease, Raynaud Syndrome
RecruitingPhase 2/3
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Scleroderma, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Roustit, PharmD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Raynaud Phenomenon, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Roustit, PharmD, PhD (+33476767856, mroustit@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984422, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.