Physical DisabilityIMPACTARNCT02124031
Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR)
An observational study of Physical Disability and Joint Function Disorder, run by Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability, Joint Function Disorder, Axis IV Problems Economic
- How many people
- 10,241 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Oct 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients > 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).
Who cannot join
- Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Disability, Joint Function Disorder, Axis IV Problems Economic, Compliance Behavior, Complications; Arthroplasty
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Disability, Joint function
- Medical subject headings
- Patient Compliance, Osteoarthritis, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
For evaluate the impact in quality of life we will use the EUROQoL score
Measured: Previous six months
Secondary outcomes (1)
Articular function
For evaluate the impact for articular function we will use the MDHAQ score, m-SACRAH score (hand) and WOMAC score (knee)
Measured: Previous six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 10,241 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Webmedica
- Responsible party
- Sponsor
- Investigators
- Rolando Espinosa, M. D., Principal investigator, National Institute of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124031
- Sponsor's protocol ID
- IMPACTAR
- Acronym
- IMPACTAR
- Status last verified
- Oct 2015
- First submitted
- 24 Apr 2014
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02124031
- Acronym / sponsor ID
- IMPACTAR / IMPACTAR
- Conditions
- Physical Disability, Joint Function Disorder, Axis IV Problems Economic, Compliance Behavior, Complications; Arthroplasty
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Disability, Joint function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,241 participants (actual)
- Lead sponsor
- Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis ReumatoideUniversity, hospital or other
- Collaborators
- Sanofi, Webmedica
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients > 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).
Key exclusion criteria (1 listed)
- Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life
Time frame: Previous six months
For evaluate the impact in quality of life we will use the EUROQoL score
1 secondary outcome
Articular function
Time frame: Previous six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando Espinosa, M. D. principal investigator
National Institute of Rehabilitation
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability and Joint Function Disorder, run by Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Previous six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.