Rheumatoid Arthritis Clinical Trial
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.
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).
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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