Ignite Creation Date:
2024-05-06 @ 3:05 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02200068
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2014-07-09
Brief Title:
CARNet Self-Monitoring and Co-driving in Rheumatology With Internet Rheumatoid Arthritis Cohort Usual Care Study
Sponsor:
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
Organization:
Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers
Study Overview
Official Title:
Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record Sanoia in Rheumatoid Arthritis Patients on Reported Outcomes
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARNet
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
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 hisher 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 eg when himherself 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 ie 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 Sanoiacom 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 145000 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 eg notepad symptoms followed by medications taken etc or more specific to RA eg 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
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 eg when himherself 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 ie 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 Sanoiacom 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 145000 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 eg notepad symptoms followed by medications taken etc or more specific to RA eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None