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OpenTrials
Completed

NCT Number: NCT02316977

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Frederiksberg, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Standford Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Day 1 and 56

    Criterion validity: day 1. Responsiveness: day 1-56

  2. PainDetect Questionnaire (PDQ)

    Time frame: Day 1

    For subgroups analysis

Other outcomes

  1. Disease Activity Score 28 (DAS28)

    Time frame: Day 1,3,56 and 58

Sponsors and collaborators

Lead sponsor

Eva Ejlersen Wæhrens

Other

Registry information

Acronym: eRehab

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2014
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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