Rheumatoid ArthritisCARNetNCT02200068
CARNet : Self-Monitoring and Co-driving in Rheumatology With Internet : Rheumatoid Arthritis Cohort (Usual Care Study)
A study testing SANOIA Website in people with Rheumatoid Arthritis, run by Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers at 13 sites in France.
Trial summary
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SANOIA Website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 13 sitesFrance
- Study dates
- Jun 2014to Apr 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 18 years.
- Patient with Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR ) / European League Against Rheumatism (EULAR) 2010 criteria.
- Patient monitored by the recruiting physician from over a year.
- Patient access who have access to an Internet broadband equipment other than on a mobile or a a smartphone
Who cannot join
- Patient already using Sanoia at the time of inclusion.
- Patient already participating in a therapeutic clinical trial in rheumatology
- Patient having no computer literacy and understanding difficulties
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
University Hospital Jean Minjoz
Besançon, 25030
Chu de La Cavale Blanche
Brest, 29069
University Hospital Gabriel-Montpied
Clermond-Ferrand, 63003
University Hospital of Grenoble - Hôpital Sud
Échirolles, 38434
Le Mans Regional Hospital
Le Mans, 72000
Private Rheumatologist
Mantes-la-Jolie, 78200
University Hospital Lapeyronie
Montpellier, 34295
University Hospital Hotel-Dieu
Nantes, 44000
University Hospital Saint-Antoine
Paris, 75012
University Hospital La Pitié Salpétrière
Paris, 75013
University Hospital Cochin
Paris, 75014
University Hospital Sud
Rennes, 35203
University Hospital Purpan
Toulouse, 31000
About this study
Official title: Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population.
However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding.
Read more
As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship.
The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period.
In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).
Read the detailed description
Recommendations of care in rheumatoid arthritis (RA) advocate for patient involvement and management of his/her own health.
The observation of the sole rate of use of websites specialized health patients might indicate that this involvement is occurring for a large number. Indeed, yet in 2010, more than 71% of French Netizen used the Internet to search for information related to their health according to a 2012 survey from the French National Order of Medical Doctors. Focusing on rheumatology, 68% of French patients have already used the Internet to search for information related to their arthritis as shown from a 2012 survey of the French Society of Rheumatology. In this medical field, these results reflect the fact that in France since years 2000, patients' associations and institutions, edited websites to offer patients a direct and easier access to information on diseases or treatments.
Nevertheless, it is useful to observe the type of service provided to the patient on these sites: the majority of these sites, even the most recent offer only the dissemination of information and never have been studied on this informative nature. These sites should be considered as an introductory step toward patient involvement.
Indeed, patients involvement is effective if they are really "active" and produce data, e.g. when him(her)self notes personal information online, manages a 'health book' virtual or self-assessing internet. In other words, involvement makes sense when it contributes to an "improvement" doctor-patient exchanges and when at last it leads to an increase in entropy.
Especially the latter type of use, i.e. the patient self-reported measure (patient-reported outcomes), can be a manner to both involve the patient in his care, and to feed the medical decision support with the certified rheumatologist. Moreover, it appears that the self-measurements in particular by the RA patient, are reliable.
In recent years, new services on the web or mobile begun to address this need and allowed patients to report issues relating to their health (current treatments, etc..), and to perform self-measures (pain, activity, morning stiffness, etc..). Notwithstanding visibility increasingly strong, it is striking to note that these tools, including those for self-measurement, have been little evaluated in terms of impact, for example on doctor-patient exchanges.
Indeed, Investigators have chosen to measure the characteristics of these exchanges, as perceived by the patient: effectiveness, quality and overall quality of care using dedicated tools.
In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).
The study will use the web-based platform (*) Sanoia.com, partner of the French Society of Rheumatology, which provides a trusted environment to its users via anonymity. This platform is recognized as innovative by the French Ministry of Research and relies on a data hosting architecture approved by the Ministry of Health. The statistical analysis of users data is limited to research purposes and placed under the dual supervision of patient associations and medical societies. These features are the source of its success in terms of audience with patients (> 145,000 health records created in September 2012).
Specifically Sanoia offers, among other benefits, Rheumatoid Arthritis (RA) patients to list their medical history and access to tools for self-measures, whether generic (e.g. notepad symptoms, followed by medications taken, etc.), or more specific to RA (e.g. RAPID3: routine assessment of patient index data, Health Assessment Questionnaire, Rheumatoid Arthritis Impact of Disease (RAID) score. Based on these data, a customized selection of information (based on an Internet monitoring performed by patient association ANDAR and validated by the medical society SFR) is displayed.
The main objective of this study is to quantify with RA patients the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the physician investigator to investigate the perceived efficacy ot the patient-physician relationship (PEPPI) Questionnaire during the 12 months observation period.
(*) : SANOIA is a personal health record platform that does not embed or to connect to social networks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SANOIA Website
- Keywords
- Perceived Efficacy of Patient Physician Interactions, Patient Reported Outcomes, Personal Health Record
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANOIA WebsiteOther
| Study group | Role | What they receive |
|---|---|---|
| PHR Group | Active comparator | This group will have access to a personal health record website SANOIA in addition to all resources they use or find online Receives: Other: SANOIA Website |
| Non-PHR Group | No intervention | This group will not be informed of the Personal Health Record Website and will use Internet as they usually do. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire
Measured: Baseline and Month 12
Secondary outcomes (10)
Rheumatoid Arthritis Impact of Disease (RAID) score
Patients connects to the e-CRF and file the French translation of the Rheumatoid Arthritis Impact of Disease (RAID) score
Measured: Baseline, Month 3, Month 6 and Month 12
Overall assessment of the patient's Health as measured by a VAS
Patients connects to the e-CRF and move a cursor on the appropriate value on a Visual Analogic Scale
Measured: Baseline, Month 3, Month 6 and Month 12
Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale
Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
Measured: Baseline, Month 3, Month 6 and Month 12
Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale
Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
Measured: Baseline, Month 3, Month 6 and Month 12
Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion
Patient reports the number of visits to the Rheumatologist
Measured: Month 3, Month 6 and Month 12
Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group
Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
Measured: Month 3 and Month 12
Unsatisfactory criteria using a pre-defined list for the PHR Group
Patients connects to the e-CRF and selects the appropriate items in a list of pre-defined criteria
Measured: Month 3 and Month 12
Spontaneous access and use of SANOIA for Non-PHR Group (usual care)
Time period and origin of access of Group 2 Patients (usual care) that incidentally used SANOIA prior or during the study
Measured: Month 12
Health Assessment Quality of Life Disability Index Questionnaire
Patients connects to the e-CRF and file the French translation of the Health Assessment Quality of Life Disability Index Questionnaire
Measured: Baseline
Co-morbidities list
Patients connects to the e-CRF and file the French translation of the 15 item (12 compulsory answers and 3 additional open items) of an adapted Comorbidities Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
- Sponsor type
- University, hospital or other
- Collaborators
- UCB France S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200068
- Sponsor's protocol ID
- 2013-A00105-40
- Acronym
- CARNet
- Status last verified
- Jun 2016
- First submitted
- 9 Jul 2014
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
PubMed 9670878Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461.
PubMed 20699241Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daures JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.
PubMed 19054825Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.
PubMed 18238788Guillemin F, Braincon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.
PubMed 1896787Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.
PubMed 24161836Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.
PubMed 21550283Gossec L, Cantagrel A, Soubrier M, Berthelot JM, Joubert JM, Combe B, Czarlewski W, Wendling D, Dernis E, Grange L, Beauvais C, Perdriger A, Nataf H, Dougados M, Servy H. An e-health interactive self-assessment website (Sanoia(R)) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients. Joint Bone Spine. 2018 Dec;85(6):709-714. doi: 10.1016/j.jbspin.2017.11.015. Epub 2017 Dec 12.
PubMed 29246532
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes
- ClinicalTrials.gov ID
- NCT02200068
- Acronym / sponsor ID
- CARNet / 2013-A00105-40
- Conditions
- Rheumatoid Arthritis
- Keywords
- Perceived Efficacy of Patient Physician Interactions, Patient Reported Outcomes, Personal Health Record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Association Accompagnement pour un Internet en Médecine et Santé au Service des UsagersUniversity, hospital or other
- Collaborators
- UCB France S.A.
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population.
However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding.
As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship.
The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period.
In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).
Detailed description
Recommendations of care in rheumatoid arthritis (RA) advocate for patient involvement and management of his/her own health.
The observation of the sole rate of use of websites specialized health patients might indicate that this involvement is occurring for a large number. Indeed, yet in 2010, more than 71% of French Netizen used the Internet to search for information related to their health according to a 2012 survey from the French National Order of Medical Doctors. Focusing on rheumatology, 68% of French patients have already used the Internet to search for information related to their arthritis as shown from a 2012 survey of the French Society of Rheumatology. In this medical field, these results reflect the fact that in France since years 2000, patients' associations and institutions, edited websites to offer patients a direct and easier access to information on diseases or treatments.
Nevertheless, it is useful to observe the type of service provided to the patient on these sites: the majority of these sites, even the most recent offer only the dissemination of information and never have been studied on this informative nature. These sites should be considered as an introductory step toward patient involvement.
Indeed, patients involvement is effective if they are really "active" and produce data, e.g. when him(her)self notes personal information online, manages a 'health book' virtual or self-assessing internet. In other words, involvement makes sense when it contributes to an "improvement" doctor-patient exchanges and when at last it leads to an increase in entropy.
Especially the latter type of use, i.e. the patient self-reported measure (patient-reported outcomes), can be a manner to both involve the patient in his care, and to feed the medical decision support with the certified rheumatologist. Moreover, it appears that the self-measurements in particular by the RA patient, are reliable.
In recent years, new services on the web or mobile begun to address this need and allowed patients to report issues relating to their health (current treatments, etc..), and to perform self-measures (pain, activity, morning stiffness, etc..). Notwithstanding visibility increasingly strong, it is striking to note that these tools, including those for self-measurement, have been little evaluated in terms of impact, for example on doctor-patient exchanges.
Indeed, Investigators have chosen to measure the characteristics of these exchanges, as perceived by the patient: effectiveness, quality and overall quality of care using dedicated tools.
In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).
The study will use the web-based platform (*) Sanoia.com, partner of the French Society of Rheumatology, which provides a trusted environment to its users via anonymity. This platform is recognized as innovative by the French Ministry of Research and relies on a data hosting architecture approved by the Ministry of Health. The statistical analysis of users data is limited to research purposes and placed under the dual supervision of patient associations and medical societies. These features are the source of its success in terms of audience with patients (> 145,000 health records created in September 2012).
Specifically Sanoia offers, among other benefits, Rheumatoid Arthritis (RA) patients to list their medical history and access to tools for self-measures, whether generic (e.g. notepad symptoms, followed by medications taken, etc.), or more specific to RA (e.g. RAPID3: routine assessment of patient index data, Health Assessment Questionnaire, Rheumatoid Arthritis Impact of Disease (RAID) score. Based on these data, a customized selection of information (based on an Internet monitoring performed by patient association ANDAR and validated by the medical society SFR) is displayed.
The main objective of this study is to quantify with RA patients the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the physician investigator to investigate the perceived efficacy ot the patient-physician relationship (PEPPI) Questionnaire during the 12 months observation period.
(*) : SANOIA is a personal health record platform that does not embed or to connect to social networks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHR Group | Active comparator | Other: SANOIA WebsiteThis group will have access to a personal health record website SANOIA in addition to all resources they use or find online |
| Non-PHR Group | No intervention | –This group will not be informed of the Personal Health Record Website and will use Internet as they usually do. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult over 18 years.
- Patient with Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR ) / European League Against Rheumatism (EULAR) 2010 criteria.
- Patient monitored by the recruiting physician from over a year.
- Patient access who have access to an Internet broadband equipment other than on a mobile or a a smartphone
Key exclusion criteria (3 listed)
- Patient already using Sanoia at the time of inclusion.
- Patient already participating in a therapeutic clinical trial in rheumatology
- Patient having no computer literacy and understanding difficulties
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 |
|---|---|---|
| SANOIA Website | Other | PHR Group |
Primary outcome
Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
Time frame: Baseline and Month 12
Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire
10 secondary outcomes
Rheumatoid Arthritis Impact of Disease (RAID) score
Time frame: Baseline, Month 3, Month 6 and Month 12
Overall assessment of the patient's Health as measured by a VAS
Time frame: Baseline, Month 3, Month 6 and Month 12
Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale
Time frame: Baseline, Month 3, Month 6 and Month 12
Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale
Time frame: Baseline, Month 3, Month 6 and Month 12
Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion
Time frame: Month 3, Month 6 and Month 12
Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group
Time frame: Month 3 and Month 12
Unsatisfactory criteria using a pre-defined list for the PHR Group
Time frame: Month 3 and Month 12
Spontaneous access and use of SANOIA for Non-PHR Group (usual care)
Time frame: Month 12
Health Assessment Quality of Life Disability Index Questionnaire
Time frame: Baseline
Co-morbidities list
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 9670878Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
- Background: PubMed 20699241Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461.
- Background: PubMed 19054825Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daures JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.
- Background: PubMed 18238788Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.
- Background: PubMed 1896787Guillemin F, Braincon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.
- Background: PubMed 24161836Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.
- Background: PubMed 21550283Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.
- Derived from this study: PubMed 29246532Gossec L, Cantagrel A, Soubrier M, Berthelot JM, Joubert JM, Combe B, Czarlewski W, Wendling D, Dernis E, Grange L, Beauvais C, Perdriger A, Nataf H, Dougados M, Servy H. An e-health interactive self-assessment website (Sanoia(R)) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients. Joint Bone Spine. 2018 Dec;85(6):709-714. doi: 10.1016/j.jbspin.2017.11.015. Epub 2017 Dec 12.
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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SANOIA Website in people with Rheumatoid Arthritis, run by Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers at 13 sites 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 3 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: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI) (time frame: Baseline and Month 12). 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 NCT02200068, which also lists 8 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 20 Jun 2016.