The aim of this study is to assess the effect of training on the measurement properties of a recently developed disease activity score based on patient reported outcomes and to investigate if such a measure could be implemented in current clinical…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary focus of this study is the effect of training on the concurrent
criterion validity of the PDASII. Primary outcome of the study will be the mean
difference between the PDASII and DAS28 at 6, 9 and 12 months after baseline.
Secondary outcome
Secondary outcomes will be other clinimetric aspects of the PDASII:
Validity
- face/content; percentage found to be comprehensive and percentage missing
elements
- construct; convergent correlation analysis with other measures of disease
activity and
related components of health assessment questionnaires, discriminant
correlation
analysis with non-related components of health assessment questionnaires
measures of disease activity and health state measures
- criterion; with joint damage progression over the course of one year
Reliability
- intraobserver intra-class correlation coefficient
Sensitivity to change
- standardised response mean
- effect size
- minimal important difference (ROC + 75th percentile)
Feasibility
- average time to complete
- average cost to complete
- percentage positive interpretability
- percentage full-completion
Acceptance
- percentage physicians and patients willing to use patient reported measure
for monitoring
Background summary
In recent years there has been a trend in medical practice towards
patient-centred care. Within rheumatology attention is being paid to finding
outcome measures with which patients can track their disease process; hereby
exploring effective and efficient ways to evaluate therapy.
Study objective
The aim of this study is to assess the effect of training on the measurement
properties of a recently developed disease activity score based on patient
reported outcomes and to investigate if such a measure could be implemented in
current clinical practice.
Study design
This study has a randomised parallel group design. Patients seen in daily
clinical practice are studied with three-monthly follow-up assessments for the
duration of one year. After being invited to take part in the study, patients
will be randomised to receive elaborate training or standard written
instructions on how to perform joint counts. The group of patients receiving
elaborate training will receive verbal and written instructions, and a video
how to assess and report joint counts. During the first two visits (out of
five) discrepancies between the PRO*s and standard clinical assessments will be
discussed in order to minimize these. The group of patients randomised not to
receive training will be given standard written instructions on how to perform
joints counts.
Intervention
During the course of one year, various patient reported measures, such as the
Patient-based Disease Activity Score (P-DASII), the modified Rheumatoid
Arthritis Disease Activity Index (RADAI-5), the Routine Assessment of Patient
Index Data (RAPID 2-5), the Patient derived Disease Activity Score 28 joint
count (Pt-DAS28) the Health Assessment Questionnaire Disability Index (HAQ-DI),
the Short Form 36 questions (SF36) and the Euroqol 5D (EQ-5D) will be
collected at baseline and three-monthly follow-up visits. A trained research
nurse will assess patients during these visits providing a Disease Activity
Score 28 joint count (DAS28) and a Clinical Disease Activity Index (CDAI),
which are currently used in clinical practice. Furthermore radiographs of the
hands and feet will be taken at baseline and twelve months follow-up to assess
joint damage progression.
Study burden and risks
Due to the nature of this study, there is no extra risk involved with
participation in de study. Patient burden will be approximately 45 minutes for
each visit.
Geert Grooteplein 8
6500HB Nijmegen
NL
Geert Grooteplein 8
6500HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis RA according to the ACR criteria
2. Patients starting on either their first DMARD or biological therapy
Exclusion criteria
Patients who are unable to complete the questionnaires/PDASII
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 | NL31935.091.10 |