Validation of a Tolerability Questionnaire in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02401620
• Other study ID #: FUN-TOC-2014-01
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: March 24, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Corporacion Parc Tauli
• Contact: Antoni Gomez Centeno, MD
• Phone: 0034937496300
• Email: msarmiento[@]es.imshealth.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

The purpose of the present study is to assess the measurement properties of a tolerability questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated will be robust and will assess the patient's tolerability to the treatment. Patients with greater tolerability will be more satisfied with their treatment.

Description:

Clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. The tolerability assessment of the different pharmacological strategies for Rheumatoid Arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. For these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice.

The first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.

This study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over 18 years old.

2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010

3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study *

4. Patients who have provided informed consent prior to taking part in the study.

• It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.

Exclusion Criteria:

1. Patients with rheumatic disease other than Rheumatoid Arthritis. Will be exclude patients with the following concomitant diseases: Rheumatic autoimmune disease other than RA; Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis; Diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than Rheumatoid Arthritis.

2. Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.

3. Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.

4. Patients who participated in interviews of the Phase I (development of the questionnaire)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona
Spain	Hospital Can Misses	Ibiza
Spain	Hospital Son Espases	Mallorca
Spain	Hospital Son Llàtzer	Mallorca
Spain	Hospital Corporacio Sanitaria Parc Tauli	Sabadell
Spain	Hospital Moisés Broggi	Sant Joan Despí	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective.	To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice	10 months	No
Secondary	the feasibility of the questionnaire by non-response rate and the time required to complete it	To assess the feasibility of the questionnaire by non-response rate and the time required to complete it	10 months	No
Secondary	the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).	To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity	10 months	No
Secondary	the reliability of the questionnaire in terms of internal consistency	To assess the reliability of the questionnaire in terms of internal consistency	10 months	No
Secondary	describe socio-demographic and clinical features of the patients recruited in the study.	To describe socio-demographic and clinical features of the patients recruited in the study.	10 months	No
Secondary	the adverse reactions (AR) reported by patients impact in the daily life.	To assess the adverse reactions (AR) reported by patients impact in the daily life	10 months	Yes
Secondary	correlation between the tolerability questionnaire and the patient satisfaction	To assess the correlation between the tolerability questionnaire and the patient satisfaction (ARTS questionnaire)	10 months	No