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CARNet : Self-Monitoring and Co-driving in Rheumatology With Internet : Rheumatoid Arthritis Cohort (Usual Care Study) (CARNet)

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ClinicalTrials.gov Identifier: NCT02200068
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
UCB France S.A.
Information provided by (Responsible Party):
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers

Brief 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.

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).


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: SANOIA Website Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes
Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Active Comparator: PHR Group
This group will have access to a personal health record website SANOIA in addition to all resources they use or find online
Other: SANOIA Website
No Intervention: Non-PHR Group
This group will not be informed of the Personal Health Record Website and will use Internet as they usually do.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rheumatoid Arthritis Impact of Disease (RAID) score [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
    Patients connects to the e-CRF and file the French translation of the Rheumatoid Arthritis Impact of Disease (RAID) score

  2. Overall assessment of the patient's Health as measured by a VAS [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
    Patients connects to the e-CRF and move a cursor on the appropriate value on a Visual Analogic Scale

  3. Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
    Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale

  4. 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 ]
    Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale

  5. Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion [ Time Frame: Month 3, Month 6 and Month 12 ]
    Patient reports the number of visits to the Rheumatologist

  6. Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group [ Time Frame: Month 3 and Month 12 ]
    Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale

  7. Unsatisfactory criteria using a pre-defined list for the PHR Group [ Time Frame: Month 3 and Month 12 ]
    Patients connects to the e-CRF and selects the appropriate items in a list of pre-defined criteria

  8. Spontaneous access and use of SANOIA for Non-PHR Group (usual care) [ Time Frame: Month 12 ]
    Time period and origin of access of Group 2 Patients (usual care) that incidentally used SANOIA prior or during the study

  9. Health Assessment Quality of Life Disability Index Questionnaire [ Time Frame: Baseline ]
    Patients connects to the e-CRF and file the French translation of the Health Assessment Quality of Life Disability Index Questionnaire

  10. Co-morbidities list [ Time Frame: Baseline ]
    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


Other Outcome Measures:
  1. Value of Perceived efficacy by the patient of patient-physician interactions (PEPPI) [ Time Frame: Month 3 and Month 6 ]
    Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02200068


Locations
France
University Hospital Jean Minjoz
Besançon, France, 25030
Chu de La Cavale Blanche
Brest, France, 29069
University Hospital Gabriel-Montpied
Clermond-Ferrand, France, 63003
University Hospital of Grenoble - Hôpital Sud
Echirolles, France, 38434
Le Mans Regional Hospital
Le Mans, France, 72000
Private Rheumatologist
Mantes-La-Jolie, France, 78200
University Hospital Lapeyronie
Montpellier, France, 34295
University Hospital Hotel-Dieu
Nantes, France, 44000
University Hospital Saint-Antoine
Paris, France, 75012
University Hospital La Pitié Salpétrière
Paris, France, 75013
University Hospital Cochin
Paris, France, 75014
University Hospital Sud
Rennes, France, 35203
University Hospital Purpan
Toulouse, France, 31000
Sponsors and Collaborators
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
UCB France S.A.

Publications:

Responsible Party: Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
ClinicalTrials.gov Identifier: NCT02200068     History of Changes
Other Study ID Numbers: 2013-A00105-40
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers:
Perceived Efficacy of Patient Physician Interactions
Patient Reported Outcomes
Personal Health Record

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases