Monitoring Spondyloarthritis With SpA-Net
TeleSpA
Effectiveness and Cost-effectiveness of Monitoring Spondyloarthritis With the Integrated eHealth System SpA-Net: a Randomized Controlled Trial
1 other identifier
interventional
200
1 country
2
Brief Summary
Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedStudy Start
First participant enrolled
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedAugust 8, 2023
August 1, 2023
2.6 years
December 1, 2020
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of scheduled and unscheduled outpatient visits to the rheumatology department.
Comparison of total number of outpatient visits in a 1-year period between intervention and control group.
1 year
Secondary Outcomes (13)
Ankylosing Spondylitis Disease Activity Score (ASDAS)
1 year
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
1 year
Global well-being patient
1 year
Patient reported pain
1 year
Disease activity according to physician
1 year
- +8 more secondary outcomes
Other Outcomes (5)
Healthcare cost per quality adjusted life year (QALY) gained after 1 year
1 year
Societal cost per QALY gained after 1 year
1 year
Quality Adjusted Life Years (QALY)
1 year
- +2 more other outcomes
Study Arms (2)
Intervention: patient initiated care + telemonitoring
EXPERIMENTALPatients in the intervention group will only have a scheduled outpatient visit at baseline and after 1 year. Patients will answer questionnaires and have routine blood tests done before every visit. At 6 months, there will be a remote monitoring check-up and results will be checked by the physician. If indicated, a telephone or video call can take place or a physical visit can be planned. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls.
Control group
NO INTERVENTIONThe standard care group will have a scheduled outpatient visit at baseline and after 1 year, and in between as usual, scheduled at the discretion of the treating rheumatologist. Prior to each visit, patients complete questionnaires in SpA-Net and have routine blood tests done. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls.
Interventions
See arm/group descriptions.
Eligibility Criteria
You may qualify if:
- Adult patient (18+ years)
- Diagnosis of SpA according to treating physician
- At least 2 years of disease duration, to be familiar with signs, symptoms, and medication
- Stable disease, defined as being in a patient acceptable symptom state according to patient AND treating physician AND no treatment change expected in the next few months
- Access to a computer, tablet and/or smartphone for the entire duration of the study
You may not qualify if:
- Insufficient mastery of Dutch language
- Incompetent to act for oneself
- Limited life expectancy
- Ongoing (or planned) pregnancy during the study period
- Patients participating in other research project(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Maastricht Universitycollaborator
- Medisch Spectrum Twentecollaborator
- Dutch Arthritis Associationcollaborator
Study Sites (2)
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Related Publications (2)
Hermans K, Webers C, Boonen A, Vonkeman HE, van Tubergen A. Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness. Lancet Rheumatol. 2024 Dec;6(12):e848-e859. doi: 10.1016/S2665-9913(24)00229-7. Epub 2024 Nov 1.
PMID: 39492125DERIVEDHermans K, Boonen A, Vonkeman HE, van Tubergen A. Effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated care for spondyloarthritis: protocol for a pragmatic multicentre randomised controlled trial (TeleSpA Study). BMJ Open. 2023 Feb 20;13(2):e067445. doi: 10.1136/bmjopen-2022-067445.
PMID: 36806136DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 17, 2020
Study Start
December 2, 2020
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
August 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share