Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR) (IMPACTAR)

Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis

The purpose of this study is to evaluate quality of life, degree of disability, treatment patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in Mexico.

Study Overview

• Status: Completed
• Conditions: Physical Disability; Complications; Arthroplasty; Compliance Behavior; Joint Function Disorder; Axis IV Problems Economic

Detailed Description

The osteoarthritis (OA) is a chronic and degenerative disease of multifactorial etiology, characterized by the gradual loss of articular cartilage. It is a question of one of the most common rheumatic disorders in the population, is the most habitual reason of pain and disability in the major adults and the first reason of surgeries of articular replacement. In Mexico, in a study of national area, the prevalence of locomotives manifestations was 26 %, with predominance in the women. Nowadays criteria exist for the classification of the OA, based on epidemiological studies, for the knee, the hip and the hand. Basically they have been established to homogenize studies of clinical epidemiological type. In other hand, the Rheumatoid Arthritis (RA) is an inflammatory, chronic, systemic disease that has more prominent manifestations in the diarthrodial joints. The disease have a wide range of characteristics, from the progressively chronic disease with variable degrees of destruction to articulate up to the extra-articular manifestations clinically evident. Demographically, the RA is the most common form of inflammatory arthritis and affects approximately 0.5 to 1 % of the world population, with an economic impact comparable with arterial coronary disease. The National Institute of Geographical Statistics (INEGI) thinks that in Mexico the population of major adults will double in the next decades, for what the impact of these rheumatic disorders will be serious and will turn into a problem of public health.

Based in the previous information, the Mexican Initiative of Patients with OA and RA (IMPACTAR), will on patient interview to increase the knowledge regarding the number of affected adults and the current treatment strategies.

This will be the first Mexican Registry related with Osteoarticular diseases.

• Study Type: Observational
• Enrollment (Actual): 10241

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

The Registry will include male and female patients older than 18 years with knee and/or hand OA and/or RA diagnosis according with the American College of Rheumatology criteria. It will include consecutive outpatients that are treated in any of the participant specialties of the study (orthopedics, rheumatology, internal medicine, rehabilitation medicine).

Description

Inclusion Criteria:

• Patients > 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).

Exclusion Criteria:

• Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	For evaluate the impact in quality of life we will use the EUROQoL score	Previous six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Articular function	For evaluate the impact for articular function we will use the MDHAQ score, m-SACRAH score (hand) and WOMAC score (knee)	Previous six months

Collaborators and Investigators

• Sponsor: Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide
• Collaborators: Sanofi; Webmedica
• Investigators: Principal Investigator: Rolando Espinosa, M. D., National Institute of Rehabilitation

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (ESTIMATE): April 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid Arthritis; Disability; Joint function
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis
• Other Study ID Numbers: IMPACTAR