Rheumatoid ArthritisELECTOR_INCT02317939
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
A study testing instruction and standard baseline instruction in people with Rheumatoid Arthritis, run by Henrik Gudbergsen at 1 site in Denmark.
Trial summary
A two-step multi-centre study with 240 rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- instruction and standard baseline instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Sep 2017
- 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
- Diagnosed with RA ≥ 12 months
- DAS28-CRP < 5,1
Who cannot join
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
Trial locations and contacts
1 site in 1 country.
About this study
A two-step multi-centre study with 240 rheumatoid arthritis patients.
Read the detailed description
A two-step multi-centre study containing:
A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data
AND
An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors
- Conditions
- Rheumatoid Arthritis
- Being tested
- instruction, standard baseline instruction
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instructionOther
online instruction tutorials at followup visits
standard baseline instructionOther
self-guidance at followup visits
| Study group | Role | What they receive |
|---|---|---|
| online instruction at followup visits | Experimental | patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home Receives: Other: instruction |
| standard baseline instruction | Active comparator | after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home Receives: Other: standard baseline instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrarater reliability of DAS28 done by patients
Measured: Baseline
Secondary outcomes (4)
Interrater agreement of DAS28CRP
Measured: Baseline
Intrarater reliability of joints counts performed by patients
Measured: Baseline
Intrarater reliability of joint scores performed by patients
Measured: 8 weeks
Inter- and intrarater realiabilty of DAS38
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Gudbergsen
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Region Capital Denmark
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
- Investigators
- Hennning Bliddal, MD, DMSc, Study director, Parker RIHenrik R Gudbergsen, MD, PhD, Principal investigator, Parker RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317939
- Sponsor's protocol ID
- 100.01
- Acronym
- ELECTOR_I
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.
PubMed 31416921
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
- ClinicalTrials.gov ID
- NCT02317939
- Acronym / sponsor ID
- ELECTOR_I / 100.01
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Region Capital Denmark
- Study start
- Dec 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Dec 2014 (estimated)
- 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.
A two-step multi-centre study with 240 rheumatoid arthritis patients.
Detailed description
A two-step multi-centre study containing:
A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data
AND
An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online instruction at followup visits | Experimental | Other: instructionpatients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home |
| standard baseline instruction | Active comparator | Other: standard baseline instructionafter the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with RA ≥ 12 months
- DAS28-CRP < 5,1
Key exclusion criteria (2 listed)
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
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 |
|---|---|---|
| instructiononline instruction tutorials at followup visits | Other | online instruction at followup visits |
| standard baseline instructionself-guidance at followup visits | Other | standard baseline instruction |
Primary outcome
Intrarater reliability of DAS28 done by patients
Time frame: Baseline
4 secondary outcomes
Interrater agreement of DAS28CRP
Time frame: Baseline
Intrarater reliability of joints counts performed by patients
Time frame: Baseline
Intrarater reliability of joint scores performed by patients
Time frame: 8 weeks
Inter- and intrarater realiabilty of DAS38
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Derived from this study: PubMed 31416921Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.
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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.
Hennning Bliddal, MD, DMSc study director
Parker RI
Henrik R Gudbergsen, MD, PhD principal investigator
Parker RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instruction and standard baseline instruction in people with Rheumatoid Arthritis, run by Henrik Gudbergsen at 1 site in Denmark.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Dec 2017. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intrarater reliability of DAS28 done by patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317939, which also lists 1 linked publication.
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 22 Dec 2017.