Validation of a Tolerability Questionnaire in Rheumatoid Arthritis

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Antoni Gomez Centeno, MD; Phone Number: 6371 0034937496300; Email: msarmiento@es.imshealth.com
• Study Contact Backup: Name: Monica Sarmiento; Phone Number: 6371 0034937496300; Email: msarmiento@es.imshealth.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic
    • Contact: Raimón Sanmartí
    • Principal Investigator: Raimón Sanmartí
  • Ibiza, Spain, 07800
    • Recruiting
    • Hospital Can Misses
    • Contact: Ana Urruticoechea
    • Principal Investigator: Ana Urruticoechea
  • Mallorca, Spain, 07010
    • Recruiting
    • Hospital Son Espases
    • Contact: Lluis Espadaler
    • Principal Investigator: Lluis Espadaler
  • Mallorca, Spain, 07198
    • Recruiting
    • Hospital Son Llàtzer
    • Contact: Inmaculada Ros
    • Principal Investigator: Inmaculada Ros
  • Sabadell, Spain, 08208
    • Recruiting
    • Hospital Corporacio Sanitaria Parc Tauli
    • Contact: Antoni Gomez Centeno
    • Principal Investigator: Antoni Gomez Centeno
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Recruiting
      • Hospital Moisés Broggi
      • Contact: Hector Coromines
      • Principal Investigator: Hector Coromines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with Rheumatoid Arthritis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
single-group studies; Patients with RA diagnosed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
the reliability of the questionnaire in terms of internal consistency	To assess the reliability of the questionnaire in terms of internal consistency	10 months
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
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
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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Study Chair: Antoni Gomez Centeno, Hospital Corporacio Parc Tauli

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: AR: arthritis rheumatoid; DMARDs: Disease-modifying antirheumatic drugs; ACR. American College of Rheumatology; EULAR: European League against rheumatology
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: FUN-TOC-2014-01