NCT02124031

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

April 24, 2014

Last Update Submit

October 22, 2015

Conditions

Keywords

OsteoarthritisRheumatoid ArthritisDisabilityJoint function

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    For evaluate the impact in quality of life we will use the EUROQoL score

    Previous six months

Secondary Outcomes (1)

  • Articular function

    Previous six months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient ComplianceOsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rolando Espinosa, M. D.

    National Institute of Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10