Rheumatoid Arthritis Clinical Trial
— CARNetOfficial 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.
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).
Status | Completed |
Enrollment | 320 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
France | University Hospital Jean Minjoz | Besançon | |
France | Chu de La Cavale Blanche | Brest | |
France | University Hospital Gabriel-Montpied | Clermond-Ferrand | |
France | University Hospital of Grenoble - Hôpital Sud | Echirolles | |
France | Le Mans Regional Hospital | Le Mans | |
France | Private Rheumatologist | Mantes-La-Jolie | |
France | University Hospital Lapeyronie | Montpellier | |
France | University Hospital Hotel-Dieu | Nantes | |
France | University Hospital Cochin | Paris | |
France | University Hospital La Pitié Salpétrière | Paris | |
France | University Hospital Saint-Antoine | Paris | |
France | University Hospital Sud | Rennes | |
France | University Hospital Purpan | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers | UCB France S.A. |
France,
Aletaha 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, Ménard 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. Erratum in: Ann Rheum Dis. 2010 Oct;69(10):1892. — View Citation
Bossert 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. — View Citation
Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daurès 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. — View Citation
Guillemin F, Brainçon 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. — View Citation
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. — View Citation
Pincus 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. — View Citation
Smolen JS, Landewé 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Value 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 | Month 3 and Month 6 | No |
Primary | 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 | Baseline and Month 12 | No |
Secondary | 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 | Baseline, Month 3, Month 6 and Month 12 | No |
Secondary | 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 | Baseline, Month 3, Month 6 and Month 12 | No |
Secondary | 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 | Baseline, Month 3, Month 6 and Month 12 | No |
Secondary | 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 | Baseline, Month 3, Month 6 and Month 12 | No |
Secondary | Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion | Patient reports the number of visits to the Rheumatologist | Month 3, Month 6 and Month 12 | No |
Secondary | 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 | Month 3 and Month 12 | No |
Secondary | 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 | Month 3 and Month 12 | No |
Secondary | 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 | Month 12 | No |
Secondary | 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 | Baseline | No |
Secondary | 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 | Baseline | No |
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