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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02316977

Acronym

eRehab

Enrollment

200

Registered

2014-12-15

Start date

2014-12-31

Completion date

2016-03-31

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Reproducibility of Results

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness	Day 1,3,56 and 58	Intrarater reliability: day 1-3 and 56-58. Criterion validity: day 1 Responsiveness: day 1-56

Secondary

Measure	Time frame	Description
Standford Health Assessment Questionnaire Disability Index (HAQ-DI)	Day 1 and 56	Criterion validity: day 1. Responsiveness: day 1-56
PainDetect Questionnaire (PDQ)	Day 1	For subgroups analysis

Other

Measure	Time frame
Disease Activity Score 28 (DAS28)	Day 1,3,56 and 58

Countries

Denmark

Outcome results