Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study

NCT02316977 | Completed

• 1 other identifier: 133.1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Standford Health Assessment Questionnaire Disability Index (HAQ-DI)

  Day 1 and 56

• PainDetect Questionnaire (PDQ)

  Day 1

Other Outcomes (1)

• Disease Activity Score 28 (DAS28)

  Day 1,3,56 and 58

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosed with RA ≥ 12 months
• DAS28-CRP \< 5,1
• Age between 18 and 85 years
• Computer and Internet connection at home

You may not qualify if:

• 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

Sponsors & Collaborators

• Eva Ejlersen Wæhrens: lead

Study Sites (1)

The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Henning Bliddal, DMSci

  The Parker Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher, PhD

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

DK (1)