Arthritis, RheumatoidNCT03428763
ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis
A study testing Homebased disease monitoring (eHealth) and Standard clinical disease monitoring in people with Arthritis, Rheumatoid and Telerehabilitation, run by Frederiksberg University Hospital at 2 sites in 2 countries.
Trial summary
The aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthritis, Rheumatoid, Telerehabilitation
- What is being tested?
- Homebased disease monitoring (eHealth) and Standard clinical disease monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Aug 2020to 18 Aug 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with rheumatoid arthritis
- Diagnosed with RA > 12 months
- Age between 18 and 85 years
- Computer and Internet connection at home and ability to employ these
- Hand function that allows self-testing of blood test at home.
Who cannot join
- Blood samples (creatinine, haemoglobin) outside lower normal limit - 5 % and upper normal limit + 5 % at screening.
- Blood samples (thrombocytes and leukocytes) outside lower normal limit - 15 % and upper normal limit + 15 % at screening
- Blood samples (ALT) outside lower normal limit - 100 % and upper normal limit + 100 % at screening
- Previously diagnosed with neutropenia and/or pancytopenia
- Dementia or other cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site
Institute of Rheumatology, Charles University
Prague, Prague, 128 50
About this study
Official title: ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis: A 6 Months Multicentre, eHealth Randomised, Non-blinded, Parallel-group, Superiority Trial
The aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA).
Read the detailed description
The aim of RA therapy is to reduce disease activity, joint destruction, symptoms, and disability. The prevailing therapeutic approach is an aggressive pharmacological disease control, with readily available conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in first line. The csDMARDs goes a long way towards reductions in disease activity, symptoms, and disability. However, if satisfactory disease control is not achieved by csDMARDS, addition of biologic medicines can be necessary.
With the efficacy of all these pharmacological options and the current view on "Treat-to-Target" (T2T), RA patients should have excellent prospects. However, despite the evidence to support a T2T strategy it is anticipated that many patients across various countries in Europe have active disease and suffer from increasing disability; this might be a consequence of bad access to optimal care, as well as possibly a lack of reimbursement of biological agents. Currently, the proposed T2T strategies are managed in the clinic by physicians, nurses and biometricians, which is expensive and time consuming for both patients and health care professionals (HCPs).
Telemonitoring and eHealth solutions for assessing patients with chronic illnesses as diabetes, asthma and hypertension have previously shown great advantages in better disease control and improvement of symptoms. A similar eHealth solution for patients with RA is expected to be advantageous both for patients and the health care system.
The current trial is designed to assess if an eHealth solution for homebased disease activity monitoring is superior to the standard clinical disease monitoring strategy with respect to T2T goals. The main research question is whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with RA.
- Conditions
- Arthritis, Rheumatoid, Telerehabilitation
- Being tested
- Homebased disease monitoring (eHealth), Standard clinical disease monitoring
- Keywords
- Arthritis, Rheumatoid, Telerehabilitation, controlled randomised trial
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homebased disease monitoring (eHealth)Device
Participants allocated to the intervention group will be trained in self-monitoring (assessment of tender of swollen joints). Further they will be instructed in using a point-of-care CRP-measuring device to measure blood concentrations of C-reactive protein at their home, and to submit the self-monitoring results on a dedicated internet platform. These procedures represent a "virtual visit".
The participants are instructed to have "virtual visit" (self-monitoring) every month from allocation. The scheduled "virtual visits" include
- Joint score by the patient
- Patient global disease activity measured on a 0-100 mm visual analogue scale.
- CRP measurement on home-based device Based on the submitted data a DAS28-CRP is calculated and recorded in the eCRF.
Standard clinical disease monitoringOther
Those allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor.
| Study group | Role | What they receive |
|---|---|---|
| Homebased disease monitoring (eHealth) | Experimental | Participants allocated to the intervention group will be trained in self-monitoring of their RA Receives: Device: Homebased disease monitoring (eHealth) |
| Standard clinical disease monitoring | Active comparator | Those allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor. Receives: Other: Standard clinical disease monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average DAS28-CRP over time
The Disease Activity Score (DAS) is a combined index that has been developed to measure the disease activity in patients with RA. It is a composite of standard clinical, laboratory data, and patient-reported data. The DAS28-CRP requires a standard blood sample (20 ml) to be drawn and analysed.
Measured: 6 months from baseline
Secondary outcomes (16)
DAS28-CRP<3.2
Proportion of patients with low disease activity (LDA) defined as DAS28-CRP<3.2
Measured: 6 months from baseline
DAS28-CRP<2.6
Proportion of patients in remission defined as DAS28-CRP<2.6
Measured: 6 months from baseline
Remission
Proportion of patients fulfilling the provisional and adapted ACR/EULAR remission criteria
Measured: 6 months from baseline
The Short Form (36) Health Survey(The SF-36)
Change in the overall scores of the short form 36 questionnaire.
The SF-36 is a patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Change in the overall scores of the short form 36 questionnaire
Swollen-joint count,
Swollen-joint count, of 28 joints examined
Measured: 6 months from baseline
Tender-joint count
Tender-joint count, of 28 joints examined
Measured: 6 months from baseline
Physician's Global Assessment
Physician's Global Assessment - 0-100 mm VAS
Measured: 6 months from baseline
Patient's Global Assessment
Patient's Global Assessment - 0-100 mm VAS
Measured: 6 months from baseline
Patient's assessment of pain
Patient's assessment of pain - 0-100 mm VAS
Measured: 6 months from baseline
HAQ-DI
HAQ-DI - score: 0-3
Measured: 6 months from baseline
High-sensitivity C-reactive protein
High-sensitivity C-reactive protein - mg/L
Measured: 6 months from baseline
Erythrocyte sedimentation
Erythrocyte sedimentation - mm/hr
Measured: 6 months from baseline
Simplified Disease Activity Index
Simplified Disease Activity Index - score 0.1 to 86.0
Measured: 6 months from baseline
Clinical Disease Activity Index
Clinical Disease Activity Index - score 0 to 76
Measured: 6 months from baseline
Rheumatoid Arthritis Impact of Disease (RAID)
7 (NRS) questions assessed as a number between 0 and 10.
Measured: 6 months from baseline
Brief illness perception questionnaire (IPQ-B)
Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7).
A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start18 Aug 2020
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Why it stopped: Technical problems with POC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current trial is designed to assess whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with RA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, DMSc, Principal investigator, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428763
- Sponsor's protocol ID
- APPI-100.02
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2018
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis: A 6 Months Multicentre, eHealth Randomised, Non-blinded, Parallel-group, Superiority Trial
- ClinicalTrials.gov ID
- NCT03428763
- Acronym / sponsor ID
- APPI-100.02
- Conditions
- Arthritis, Rheumatoid, Telerehabilitation
- Keywords
- Arthritis, Rheumatoid, Telerehabilitation, controlled randomised trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems with POC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 12 Feb 2018 (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 aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA).
Detailed description
The aim of RA therapy is to reduce disease activity, joint destruction, symptoms, and disability. The prevailing therapeutic approach is an aggressive pharmacological disease control, with readily available conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in first line. The csDMARDs goes a long way towards reductions in disease activity, symptoms, and disability. However, if satisfactory disease control is not achieved by csDMARDS, addition of biologic medicines can be necessary.
With the efficacy of all these pharmacological options and the current view on "Treat-to-Target" (T2T), RA patients should have excellent prospects. However, despite the evidence to support a T2T strategy it is anticipated that many patients across various countries in Europe have active disease and suffer from increasing disability; this might be a consequence of bad access to optimal care, as well as possibly a lack of reimbursement of biological agents. Currently, the proposed T2T strategies are managed in the clinic by physicians, nurses and biometricians, which is expensive and time consuming for both patients and health care professionals (HCPs).
Telemonitoring and eHealth solutions for assessing patients with chronic illnesses as diabetes, asthma and hypertension have previously shown great advantages in better disease control and improvement of symptoms. A similar eHealth solution for patients with RA is expected to be advantageous both for patients and the health care system.
The current trial is designed to assess if an eHealth solution for homebased disease activity monitoring is superior to the standard clinical disease monitoring strategy with respect to T2T goals. The main research question is whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with RA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The current trial is designed to assess whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with RA.
| Arm | Type | Receives |
|---|---|---|
| Homebased disease monitoring (eHealth) | Experimental | Device: Homebased disease monitoring (eHealth)Participants allocated to the intervention group will be trained in self-monitoring of their RA |
| Standard clinical disease monitoring | Active comparator | Other: Standard clinical disease monitoringThose allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with rheumatoid arthritis
- Diagnosed with RA > 12 months
- Age between 18 and 85 years
- Computer and Internet connection at home and ability to employ these
- Hand function that allows self-testing of blood test at home.
Key exclusion criteria (6 listed)
- Blood samples (creatinine, haemoglobin) outside lower normal limit - 5 % and upper normal limit + 5 % at screening.
- Blood samples (thrombocytes and leukocytes) outside lower normal limit - 15 % and upper normal limit + 15 % at screening
- Blood samples (ALT) outside lower normal limit - 100 % and upper normal limit + 100 % at screening
- Previously diagnosed with neutropenia and/or pancytopenia
- Dementia or other cognitive/physical deficiency that prevents participation
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 |
|---|---|---|
| Homebased disease monitoring (eHealth)Participants allocated to the intervention group will be trained in self-monitoring (assessment of tender of swollen joints). Further they will be instructed in using a point-of-care CRP-measuring device to measure blood concentrations of C-reactive protein at their home, and to submit the self-monitoring results on a dedicated internet platform. These procedures represent a "virtual visit". The participants are instructed to have "virtual visit" (self-monitoring) every month from allocation. The scheduled "virtual visits" include * Joint score by the patient * Patient global disease activity measured on a 0-100 mm visual analogue scale. * CRP measurement on home-based device Based on the submitted data a DAS28-CRP is calculated and recorded in the eCRF. | Device | Homebased disease monitoring (eHealth) |
| Standard clinical disease monitoringThose allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor. | Other | Standard clinical disease monitoring |
Primary outcome
Average DAS28-CRP over time
Time frame: 6 months from baseline
The Disease Activity Score (DAS) is a combined index that has been developed to measure the disease activity in patients with RA. It is a composite of standard clinical, laboratory data, and patient-reported data. The DAS28-CRP requires a standard blood sample (20 ml) to be drawn and analysed.
16 secondary outcomes
DAS28-CRP<3.2
Time frame: 6 months from baseline
DAS28-CRP<2.6
Time frame: 6 months from baseline
Remission
Time frame: 6 months from baseline
The Short Form (36) Health Survey(The SF-36)
Time frame: Change in the overall scores of the short form 36 questionnaire
Swollen-joint count,
Time frame: 6 months from baseline
Tender-joint count
Time frame: 6 months from baseline
Physician's Global Assessment
Time frame: 6 months from baseline
Patient's Global Assessment
Time frame: 6 months from baseline
Patient's assessment of pain
Time frame: 6 months from baseline
HAQ-DI
Time frame: 6 months from baseline
High-sensitivity C-reactive protein
Time frame: 6 months from baseline
Erythrocyte sedimentation
Time frame: 6 months from baseline
Simplified Disease Activity Index
Time frame: 6 months from baseline
Clinical Disease Activity Index
Time frame: 6 months from baseline
Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: 6 months from baseline
Brief illness perception questionnaire (IPQ-B)
Time frame: 6 months from baseline
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 27 Feb 2025.
Related trials for Arthritis, Rheumatoid
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Henning Bliddal, DMSc principal investigator
The Parker Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homebased disease monitoring (eHealth) and Standard clinical disease monitoring in people with Arthritis, Rheumatoid and Telerehabilitation, run by Frederiksberg University Hospital at 2 sites in 2 countries.
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 5 inclusion and 6 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Denmark. 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?
Average DAS28-CRP over time (time frame: 6 months from baseline). 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 27 Feb 2025.