This study aims (i)to estimate the monthly change of functional status (HAQ) and self-reported disease activity(RADAI and VAS global) among patient diagnosed with RA, (ii) to estimate the relationship between the changes on DAS28 and changes on theā¦
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
RADAI
HAQ
VAS global
Secondary outcome
VAS-fatigue
Coping
Self-efficacy
Ilness perception
Background summary
Rheumatoid arthritis(RA) is an auto-immune disease affecting the joints of the
body. Arthritis and bone erosions are characteristic, causing pain and
functional limitations of the involved joints. In the early days RA was mostly
untreatable, but over the last 20 years drug treatment has come available
which makes arthritis treatable and bone erosions preventable.
By reducing the arthritis activity, it is likely bone erosions could be
prevented. This could be done by an adequate prescription of medication,
depending on the level of disease activity. This is normally done by the
consultant during the visits at the clinic. As flares in RA are very
unpredictable, flares could occur just after a visit at the clinic. This will
be unobserved by the consultant, but could need a change in medication. In this
study we would like to evaluate whether patient could determine their own
disease-activity by filling out questionnaires measuring functional status and
disease-activity.
If this would be succesful, it could mean that patient will be more able to
management the point when there is an urge to see a consultant and change in
medication may be required.
Study objective
This study aims (i)to estimate the monthly change of functional status (HAQ)
and self-reported disease activity(RADAI and VAS global) among patient
diagnosed with RA, (ii) to estimate the relationship between the changes on
DAS28 and changes on the HAQ, RADAI and VAS global and (iii) to determine a
cut point on change scores on HAQ, RADAI and VAS global which indicates a
flare of disease activity (DAS28>3.2) requiring treatment.
Study design
Longitudinal predictive cohort study, predicting disease flares (DAS28>3.2) by
HAQ, RADAI and VAS global.
150 RA patients will be invited to participate in this study. A letter will be
send to them including a patient information leaflet about the study. Patients
could be included if they are using at least 3 months 'disease modyfing drugs',
age over 17 years and sufficient knowledge to read and write Dutch. Patient
with severe psychiatric illness or personalty disorders, no access to a
computer at home or no access to internet or email will be excluded.
Patients will be asked to complete a questionnaire monthly via internet and to
visit the nurse-practioner 3-monthly over a period of 1 year. The
nurse-practioner will determine the disease-activity score(DAS) using physical
examination.
Data will be analysed using STATA 8.0. Linear regression will be used to
evaluate the relationship between changes in DAS28 scores and change in scores
on the self-reported measures. Multivariate linear regression will be used to
predict the change in DAS28-score by the change scores of the HAQ, RADAI and
VAS global. Receiver operating characteristic (ROC) curves will be plotted to
explore sensitivity and specificity of a flare (DAS>3.2) for all possible cut
off points of the change in HAQ, RADAI and VAS. Discriminate ability will be
calculated using the area under the curve.
Study burden and risks
It will take about 30 minutes to fill out the baseline questionnaire
It will take 30 minutes a visit to the nurse practioner
Completing the follow-up questionnaires will take about 10-15 minutes
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with ACR-classified RA using DMARDs for at least 3 months.
Exclusion criteria
younger than 18 years
Not able to read and write in Dutch
Severe psychiatric illness or personality disorders
Not able to use a computer
No availability of internet and/or email
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL19149.078.07 |