Arthritis, Rheumatoid Clinical Trial
— eRehabOfficial title:
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
| NCT number | NCT02316977 |
| Other study ID # | 133.1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2014 |
| Est. completion date | March 2016 |
| Verified date | November 2023 |
| Source | Parker Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Diagnosed with RA = 12 months - DAS28-CRP < 5,1 - Age between 18 and 85 years - Computer and Internet connection at home Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg | Frederiksberg |
| Lead Sponsor | Collaborator |
|---|---|
| Eva Ejlersen Wæhrens |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Disease Activity Score 28 (DAS28) | Day 1,3,56 and 58 | ||
| Primary | 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 | Day 1,3,56 and 58 | |
| Secondary | Standford Health Assessment Questionnaire Disability Index (HAQ-DI) | Criterion validity: day 1. Responsiveness: day 1-56 | Day 1 and 56 | |
| Secondary | PainDetect Questionnaire (PDQ) | For subgroups analysis | Day 1 |
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