Primary Objective: To evaluate the *Triple Aim* performance of Care Pathway Technology for RA: - Evaluate and compare predefined RA health outcomes; Disease activity measured by DAS 28 joint score at baseline, month 12; RAPID3, HAQ-DI at baseline…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: proportion of patients in clinical disease remission: DAS28
joint score < 2.6 at clinic visits at baseline and month 12; RAPID3 score <3,
HAQ-DI < 0.5 at baseline, months 12.
Secondary outcome
- Evaluate differences in use of clinical services by comparing the number of
- Clinic visits,
- Hospitalizations,
- Laboratory procedures,
- Medication alteration (both intensification and tapering) and
- Intra-articular joint injections
- Patient & Provider Experiences: proportion of patients and providers who
would recommend this platform to others (Net Promotor score: > 0: good, > 30:
great, > 50: excellent); plus the System Usability Scale (SUS).
- Proportion of patients with >= 20% increase in Quality of Life (VAS) at 12
months compared to baseline. ( Visual Analogue Scale (VAS): Quality of Life >= 2
points increase on a scale of 1-100)
- Proportion of patients with >= 20% increase in Productivity (VAS) at 12 months
compared to baseline. ( Visual Analogue Scale (VAS): Productivity >= 2 points
increase on a scale of 1-100)
Background summary
Regular clinical monitoring of disease activity is a vital part of current
treatment strategies for Rheumatoid Arthritis (RA), such as Treat to Target (
T2T) and Tight Control. The management of RA by Care Pathway Technology can, by
providing personalized medicine, optimize treatment outcome, improve patient
satisfaction and potentially lessen the burden on RA clinical care by reducing
the number of clinical visits.
Study objective
Primary Objective: To evaluate the *Triple Aim* performance of Care Pathway
Technology for RA:
- Evaluate and compare predefined RA health outcomes; Disease activity measured
by DAS 28 joint score at baseline, month 12; RAPID3, HAQ-DI at baseline and
month 12, DEARhealth Quality of life questionnaire and Productivity and
Activity (WPAI) indices at baseline, month 4, 8, 12.
- Evaluate the user experience of patients, their caregivers and provider teams.
- Evaluate differences in use of clinical services (number of clinic visits,
hospitalizations, lab procedures, medication alterations and joint injections )
Study design
: A prospective randomized-controlled study in Rheumatoid Arthritis patients,
who will be included during their regular outpatient visits to the rheumatology
department of the Medical Center Leeuwarden (MCL).
Study burden and risks
There will be no additional risk for patients: all treatment is conform regular
care. Use of the DEARhealth app should in the future provide a time saving
alternative to clinical RA care.
henri dunantweg 2
Leeuwarden 8934AD
NL
henri dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- A diagnosis of RA existing for at least five years and meeting the 2010
American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)
criteria. (17)
- Willing and able to independently provide written informed consent
- Owns and is able to use a mobile device ( Android or iOS)
Exclusion criteria
- Insufficient knowledge of the Dutch language to engage with the eHealth tool
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 | NL79073.099.21 |