The overall objective of this proposal is to implement a digital care platform to monitor rheumatoid artritis disease activity between scheduled rheumatologist visits over 12 months. The essential components in this system are as follows: (1) the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* health care utilization as measured by the mean number of outpatient clinic
visits with a rheumatologist during the 12 months trial period.
* disease activity as measured by the mean DAS28 at 12 months
Secondary outcome
* Health care satisfaction on a 10 point scale as recommended by the Institute
for Healthcare Improvement. 38 Using any number from 0 to 10, where 0 is the
worst health care possible and 10 is as the best health care possible, what
number would you use to rate all your health care in the last 12 months?*
* Patient empowerment as measured by the Effective Consumer scale (EC-17)
* Disease activity as measured by Routine Assessment of Patient Index Data
(RAPID3)
* Patient-physician interaction as measured by the Perceived Efficacy in
Patient-Physician Interactions Questionnaire (PEPPI)
* Treatment satisfaction as measured by the Treatment Satisfaction
Questionnaire for Medication (the TSQM questionnaire)
* Medication adherence as measured by the CQR5 Compliance Questionnaire
Rheumatology (CQR5)
* Participation as measured by Work Productivity and Activity Impairment
Questionnaire (WPAI)
* Overall costs of health care utilization including medication use and number
of telephone appointments with a rheumatology health care professional as
measured by a detailed questionnaire and retrieved from the Reade EMR
* Treating physician satisfaction as measured by a physician visit and exit form
* Qualitative data derived from focus group discussions at the end of the trial
period
* Exploratory analysis on the causes of flares
* completion rates of weekly surveys as proxies for patient engagement and
overall feasibility.
* system usability score (SUS)
Background summary
Rising health care costs, increasing elderly population and shortage of
personel forces us to think about alternative ways how to organize our health
care system. Telemedicine with self measurement of disease activity could be
one of the key ingredients of the health care system of the future. It has been
shown, for instance in inflammatory bowel disease, to empower patients to take
care of their own health and reduce outpatient clinic visits.
Study objective
The overall objective of this proposal is to implement a digital care platform
to monitor rheumatoid artritis disease activity between scheduled
rheumatologist visits over 12 months. The essential components in this system
are as follows:
(1) the MijnReuma Reade App,
(2) integration with the Reade Electronic Medical Record (EMR)
(3) a preprogrammed algorithm to identify increases in disease activity to
support self-management and self-initiated care
(4) personalized information regarding self-management of disease activity.
Study design
This is a single blinded pragmatic randomized controlled trial (RCT) of a
digital care platform. The study design is similar to the telemedicine study in
inflammatory bowel disease by de Jong et al. published in the Lancet in
2017.Participants randomized to the intervention group receive instructions, a
username and a password for the app. Participants will use the App for 12
months and are instructed to complete a weekly questionnaire through the App
and plan at least one routine outpatient visit during the trial period.
Additional follow-up visits are scheduled on the basis of flares as recognized
by the app or at the requests of individual patients.
Patients in the standard care group continue their routine follow-up visits as
deemed necessary by the rheumatologist (*usual care*), with an opportunity to
schedule an extra visit if symptoms relapse.
Intervention
The digital care platform as described in the objective.
Study burden and risks
Patients will be seen twice (at T0 and T12 months) at the rheumatology
outpatient clinic, and the visits will be combined as much as possible with
regular visits. During these visits the burden consists of:
- undergoing physical examination of the joints
-filling out a questionnaire.
-regular venapunction to determine the disease activity score DAS28 and
medication control, (ESR, CRP, Hb, Leucocytes, Thrombocytes, ALAT en kreatinin)
At 3,6 and 9 months, patients will complete a (digital) questionnaire at home
The risks of the examination, venapuntion and the questionnaire are minimal
dr Jan van Breemenstraat 2
Amsterdam 1056AB
NL
dr Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Listed location countries
Age
Inclusion criteria
To be included in this study, participants must:
* be diagnosed with rheumatoid arthritis by a rheumatologist
* have a disease duration of at least 2 years
* be in low disease activity or remission (DAS28 < 3,2) at moment of inclusion
* be taking a disease-modifying antirheumatic drug (DMARD)
* own a mobile device with an Android or iOS operating system
* be at least 18 years old
* be able to read and speak Dutch
Exclusion criteria
* taking part in another intervention study
* Medication change: start or stop of a DMARD(biologicals, or
conventional DMARDS*) in the last 6 months. , *Methotrexate, cyclosporine,
cyclophosphamide, gold injections, hydroxychloroquine, leflunomide,
mycophenolate, sulfasalazine, corticosteroids.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67704.029.19 |