CARNet : Self-Monitoring and Co-driving in Rheumatology With Internet : Rheumatoid Arthritis Cohort (Usual Care Study) (CARNet)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02200068 |
|
Recruitment Status :
Completed
First Posted : July 25, 2014
Last Update Posted : June 20, 2016
|
Sponsor:
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
Collaborator:
UCB France S.A.
Information provided by (Responsible Party):
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Rheumatoid arthritis
| 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 :
- 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 :
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |