Rheumatoid ArthritisR@HNCT05725577
Rheum@Home: RA Remote Patient Monitoring
A study testing care via the telemedicine system and Routine care in people with Rheumatoid Arthritis, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- care via the telemedicine system and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive patients;
- signed, written informed consent;
- 18 -75 years of age;
- clinical diagnosis of RA;
- ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
- able to read and understand simple Dutch language instructions;
- ownership or access to a smartphone, tablet or computer and having internet access;
- able to conduct a teleconsultation on a smartphone, tablet or computer.
Who cannot join
- severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rheum@Home: Rheumatoid Arthritis Care in the 21th Century
The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.
Participants will be asked to
- complete questionaires every 4 weeks
- perform a walking test every 4 weeks
- routine lab
- routine disease activity measurement by a qualified assessor
Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.
- Conditions
- Rheumatoid Arthritis
- Being tested
- care via the telemedicine system, Routine care
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care via the telemedicine systemOther
Care via the telemedicine system
Routine careOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| Care via the telemedicine system | Other | Intervention Receives: Other: care via the telemedicine system |
| Standard care | Other | Control Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of rheumatology outpatient visits with rheumatologists and nurses
Number of rheumatology outpatient visits with rheumatologists and nurses
Measured: 12 month period
Patient-reported quality of care
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
Measured: 12 month period
Secondary outcomes (15)
Number of rheumatology teleconsultations (email, telephone, video)
Number of rheumatology teleconsultations (email, telephone, video)
Measured: 12 month period
DAS28
Disease Activity Score
Measured: 12 month period
PROMs: disease activity score (RAPID3)
PROMs: disease activity score (RAPID3)
Measured: 12 month period
PROMs: Patient acceptable symptom state (PASS)
PROMs: Patient acceptable symptom state (PASS)
Measured: 12 month period
PROMs: participation (WPAI)
PROMs: participation (WPAI)
Measured: 12 month period
PROMs: pain (NRS)
PROMs: pain (NRS)
Measured: 12 month period
PROMs: fatigue (NRS)
PROMs: fatigue (NRS)
Measured: 12 month period
PROMs: physical function (HAQ-DI)
PROMs: physical function (HAQ-DI)
Measured: 12 month period
PROMs: health related quality of life (EQ5D)
PROMs: health related quality of life (EQ5D)
Measured: 12 month period
PROMs: health related quality of life (SF36)
PROMs: health related quality of life (SF36)
Measured: 12 month period
Physical performance: 50 meter walking test
Physical performance: 50 meter walking test
Measured: 12 month period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
(S)AE's assessed by CTCAE v4.0
Measured: 12 month period
Cost-effectiveness: healthcare utilization questionnaire
Cost-effectiveness: healthcare utilization questionnaire
Measured: 12 month period
Patient experience: System usability scale (SUS)
Patient experience: System usability scale (SUS)
Measured: 12 month period
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Measured: 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023
Why it stopped: App company failed to produce a working application
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Reade Rheumatology Research Institute, Maastricht University Medical Center
- Responsible party
- Principal investigator, Harald E. Vonkeman, Medisch Spectrum Twente
- Investigators
- Harald Vonkeman, MD, Principal investigator, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725577
- Sponsor's protocol ID
- R@H
- Acronym
- R@H
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheum@Home: Rheumatoid Arthritis Care in the 21th Century
- ClinicalTrials.gov ID
- NCT05725577
- Acronym / sponsor ID
- R@H / R@H
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: App company failed to produce a working application
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- University of Twente, Reade Rheumatology Research Institute, Maastricht University Medical Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.
Participants will be asked to
- complete questionaires every 4 weeks
- perform a walking test every 4 weeks
- routine lab
- routine disease activity measurement by a qualified assessor
Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care via the telemedicine system | Other | Other: care via the telemedicine systemIntervention |
| Standard care | Other | Other: Routine careControl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- all consecutive patients;
- signed, written informed consent;
- 18 -75 years of age;
- clinical diagnosis of RA;
- ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
Key exclusion criteria (1 listed)
- severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care via the telemedicine systemCare via the telemedicine system | Other | Care via the telemedicine system |
| Routine careRoutine care | Other | Standard care |
Primary outcome
Number of rheumatology outpatient visits with rheumatologists and nurses
Time frame: 12 month period
Number of rheumatology outpatient visits with rheumatologists and nurses
Patient-reported quality of care
Time frame: 12 month period
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
15 secondary outcomes
Number of rheumatology teleconsultations (email, telephone, video)
Time frame: 12 month period
DAS28
Time frame: 12 month period
PROMs: disease activity score (RAPID3)
Time frame: 12 month period
PROMs: Patient acceptable symptom state (PASS)
Time frame: 12 month period
PROMs: participation (WPAI)
Time frame: 12 month period
PROMs: pain (NRS)
Time frame: 12 month period
PROMs: fatigue (NRS)
Time frame: 12 month period
PROMs: physical function (HAQ-DI)
Time frame: 12 month period
PROMs: health related quality of life (EQ5D)
Time frame: 12 month period
PROMs: health related quality of life (SF36)
Time frame: 12 month period
Physical performance: 50 meter walking test
Time frame: 12 month period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 month period
Cost-effectiveness: healthcare utilization questionnaire
Time frame: 12 month period
Patient experience: System usability scale (SUS)
Time frame: 12 month period
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Time frame: 12 month period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Vonkeman, MD principal investigator
University of Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care via the telemedicine system and Routine care in people with Rheumatoid Arthritis, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of rheumatology outpatient visits with rheumatologists and nurses (time frame: 12 month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.