Arthritis, RheumatoideRehabNCT02316977
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
An observational study of Arthritis, Rheumatoid, run by Eva Ejlersen Wæhrens at 1 site in Denmark.
Trial summary
The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- 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
Study population: All adult patients, diagnosed with RA, referred for regular controls in the rheumatology clinic at Copenhagen University Hospital, Bispebjerg and Frederiksberg, will be screened via the database, DANBIO, for in- and exclusion criteria.
Who may be able to join
- Diagnosed with RA ≥ 12 months
- DAS28-CRP < 5,1
- Age between 18 and 85 years
- Computer and Internet connection at home
Who cannot join
- Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening
- Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening
- Blood samples (ALAT) outside the reference limit -/+ 100 % at screening
- 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.
Denmark1 site
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Frederiksberg, 2000
About this study
The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis.
The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home.
Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Reproducibility of Results
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness
Intrarater reliability: day 1-3 and 56-58. Criterion validity: day 1 Responsiveness: day 1-56
Measured: Day 1,3,56 and 58
Secondary outcomes (2)
Standford Health Assessment Questionnaire Disability Index (HAQ-DI)
Criterion validity: day 1. Responsiveness: day 1-56
Measured: Day 1 and 56
PainDetect Questionnaire (PDQ)
For subgroups analysis
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Ejlersen Wæhrens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Ejlersen Wæhrens, Parker Research Institute
- Investigators
- Henning Bliddal, DMSci, Study director, The Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316977
- Sponsor's protocol ID
- 133.1
- Acronym
- eRehab
- Status last verified
- Nov 2023
- First submitted
- 8 Dec 2014
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
- ClinicalTrials.gov ID
- NCT02316977
- Acronym / sponsor ID
- eRehab / 133.1
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Reproducibility of Results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eva Ejlersen WæhrensUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 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.
The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis.
The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home.
Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients, diagnosed with RA, referred for regular controls in the rheumatology clinic at Copenhagen University Hospital, Bispebjerg and Frederiksberg, will be screened via the database, DANBIO, for in- and exclusion criteria.
Key inclusion criteria (4 listed)
- Diagnosed with RA ≥ 12 months
- DAS28-CRP < 5,1
- Age between 18 and 85 years
- Computer and Internet connection at home
Key exclusion criteria (5 listed)
- Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening
- Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening
- Blood samples (ALAT) outside the reference limit -/+ 100 % at screening
- 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.
Primary outcome
ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness
Time frame: Day 1,3,56 and 58
Intrarater reliability: day 1-3 and 56-58. Criterion validity: day 1 Responsiveness: day 1-56
2 secondary outcomes
Standford Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Day 1 and 56
PainDetect Questionnaire (PDQ)
Time frame: Day 1
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 Nov 2023.
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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.
Henning Bliddal, DMSci study director
The Parker Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Eva Ejlersen Wæhrens 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 4 inclusion and 5 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 Nov 2023. 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?
ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness (time frame: Day 1,3,56 and 58). 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 22 Nov 2023.