Patient Reported Outcomes Reported Via PC / Tablet Home Versus Touch Screen at Hospital Among Patients With Arthritis

Rheumatoid Arthritis Clinical Trial

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Official title:

Patient Reported Outcome Measures Reported Into the Danish Arthritis Registry (DANBIO) Via Computer or Tablet at Home Versus Touch Screen at the Outpatient Clinic Among Patients With Axial Spondyloarthritis or Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818478
• Other study ID #: 100.03
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: February 7, 2017
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate if electronic reporting of patient reported outcome measures from home is comparable to the traditional touch-screen solution to hospital among patients with rheumatoid arthritis and axial spondyloarthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Rheumatoid arthirtis OR axial spondyloarthritis

• Active treatment and monitoring of the Knowledge Center for Rheumatology and Spine diseases, Rigshospitalet, Denmark

• Patients must have reported patient reported outcome measures via DANBIOs touch-screen solution = 3 times

Exclusion Criteria

• Impaired vision

• Non-Danish speaking

• No electronic device at home,, tablet or computer

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Rheumatoid Arthritis
• Spondylarthritis

Intervention

Other:
• Reporting of patient reported outcome measures
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Henrik Gudbergsen	Rigshospitalet, Denmark, The DANBIO registry, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking questionnaire	Smoking habits (I currently smoke; if smoking, then how many cigarettes, pibes, cigarillos, cigars and/or cheroots per day / I smoke from time to time; less than 1 cigarettes, or an equivalent amount, per day / I have stopped smoking; year of cessation / I have never smoked)	48 hours
Other	Alcohol consumption (units consumed per week)		48 hours
Other	Exercise questionnaire	Level of exercise; "exercise that causes an increased pulse and/or a feeling of being breathless" (5 times per week / 3-4 times per week / 1-2 times per week / 1-2 times per month / no regular exercising / I do not exercise)	48 hours
Other	Medical conditions questionnaire	Diagnosis of other medical conditions; "Has a doctor ever said that you have or have had the following diseases?" (hypertension / diabetes / tuberculosis / angina / hypercholesterolemia / heart attack / brain haemorrhage / asthma / psoriasis / chronic bronchitis / osteoporosis / ulcer / liver disease / kidney disease / depression / inflammatory bowel disease or Crohns disease / cancer / multiple sclerosis / thyroid disease)	48 hours
Primary	HAQ	The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis	48 hours
Secondary	100 mm VAS global	Assessed via a visual analogue scale (VAS)	48 hours
Secondary	100 mm VAS pain	Assessed via a visual analogue scale (VAS)	48 hours
Secondary	100 mm VAS fatigue	Assessed via a visual analogue scale (VAS)	48 hours
Secondary	BASDAI	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis	48 hours
Secondary	BASFI	The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis	48 hours
Secondary	BASDAI 5 & 6	Questions 5 and 6 in BASDAI	48 hours