Back to resultsHome Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study (ELECTOR_I)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
instruction
standard baseline instruction
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with RA ≥ 12 months
- DAS28-CRP < 5,1
Exclusion Criteria:
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
Sites / Locations
- Department of Rheumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
online instruction at followup visits
standard baseline instruction
Arm Description
patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home
Outcomes
Primary Outcome Measures
Intrarater reliability of DAS28 done by patients
Secondary Outcome Measures
Interrater agreement of DAS28CRP
Intrarater reliability of joints counts performed by patients
Intrarater reliability of joint scores performed by patients
Inter- and intrarater realiabilty of DAS38
Full Information
NCT ID
NCT02317939
First Posted
December 8, 2014
Last Updated
December 20, 2017
Sponsor
Henrik Gudbergsen
Collaborators
Charles University, Czech Republic, Region Capital Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02317939
Brief Title
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Acronym
ELECTOR_I
Official Title
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henrik Gudbergsen
Collaborators
Charles University, Czech Republic, Region Capital Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A two-step multi-centre study with 240 rheumatoid arthritis patients.
Detailed Description
A two-step multi-centre study containing:
A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data
AND
An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
online instruction at followup visits
Arm Type
Experimental
Arm Description
patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
Arm Title
standard baseline instruction
Arm Type
Active Comparator
Arm Description
after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home
Intervention Type
Other
Intervention Name(s)
instruction
Intervention Description
online instruction tutorials at followup visits
Intervention Type
Other
Intervention Name(s)
standard baseline instruction
Intervention Description
self-guidance at followup visits
Primary Outcome Measure Information:
Title
Intrarater reliability of DAS28 done by patients
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Interrater agreement of DAS28CRP
Time Frame
Baseline
Title
Intrarater reliability of joints counts performed by patients
Time Frame
Baseline
Title
Intrarater reliability of joint scores performed by patients
Time Frame
8 weeks
Title
Inter- and intrarater realiabilty of DAS38
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with RA ≥ 12 months
DAS28-CRP < 5,1
Exclusion Criteria:
Dementia or other linguistic/cognitive/physical deficiency that prevents participation
Vision impairment that prevents the use of the devices and computer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hennning Bliddal, MD, DMSc
Organizational Affiliation
Parker RI
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henrik R Gudbergsen, MD, PhD
Organizational Affiliation
Parker RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology
City
Frederiksberg
State/Province
Capital Region
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31416921
Citation
Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.
Results Reference
derived
Learn more about this trial
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
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