Validity and feasability of self-assessment of joints by patients with rheumatoid arthritis and the influence of elaborate training.

The Patient based Disease Activity Score (PDASII) validation study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20270

Enrollment

200

Registered

2010-11-25

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Rheumatoid Arthritis, reumatoïde artritis, patient reported outcomes, patiënt gerapporteerde uitkomsten, self assessed joint counts, zelfonderzoek, training,PDASII, validation, validatie, clinimetrics, klinimetrie

Interventions

Standard joint assessment instructions vs elaborate joint assessment training by means of extended written instructions including photographs, an instructional video on the performance of self-assessm

Eligibility

Inclusion criteria

Inclusion criteria: 1. Early RA patients seen 3 months post diagnosis or; 2. Patients starting on immunomodulating therapy (biological).

Exclusion criteria

Exclusion criteria: 1.Patients younger than 18 years of age; 2.Patients totally incapable of performing the PDASII evaluation; 3.Patients unwilling to be randomised between training groups.

Design outcomes

Primary

Measure	Time frame
Concurrent longitudinal validity of the PDASII with the DAS28 at 6, 9 and 12 months follow-up by means of a random effect model with training yes/no as a independent variable.	—

Secondary

Measure	Time frame
Validity: 1. Face/content: Percentage found to be comprehensive versus missing elements; 2. 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; 3. Predictive analysis of PDASII with joint damage progression. Reliability: 1. PDASII intrarater intra-class correlation coefficient. Sensitivity to change: 1. Standardised response mean; 2. Effect size; 3. Minimal important difference (ROC + 75th percentile). Training: The above mentioned analyses can be performed with ‘training’ as an covariate to assess the effect of having received training on the measurement properties of the PDASII.	—

Measure

Time frame

Validity: 1. Face/content: Percentage found to be comprehensive versus missing elements; 2. 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; 3. Predictive analysis of PDASII with joint damage progression. Reliability: 1. PDASII intrarater intra-class correlation coefficient. Sensitivity to change: 1. Standardised response mean; 2. Effect size; 3. Minimal important difference (ROC + 75th percentile). Training: The above mentioned analyses can be performed with ‘training’ as an covariate to assess the effect of having received training on the measurement properties of the PDASII.

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Contacts

Public ContactJos Hendrikx

Postbus 9109

J.Hendrikx@reuma.umcn.nl+31 (0)24 3617547

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)