Contact information
Type
Scientific
Primary contact
Dr Agustín Gómez de la Cámara
ORCID ID
Contact details
Hospital Universitario 12 de Octubre
Clinical Epidemiology Research Unit
Mother and Child Building
Basement -2
Avenida de Córdoba s/n
Madrid
28041
Spain
acamara@h12o.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Study of the clinical benefit and quality of life perception in patients with osteoarthritis of the hip and the knee. Evaluation based on a proactive follow-up intervention made by primary care physicians. Experimental open, randomized and controlled study.
Acronym
ARTRO-pro_AP
Study hypothesis
Despite the availability of evidence-based guidelines for the management of asymptomatic chronic diseases such as osteoarthritis, physicians often do not initiate, intensify or optimize therapy when indicated, so that patients are not treated effectively. This phenomenon is known as clinical inertia. The main objective of this study was to evaluate whether an intervention on primary care physicians to avoid clinical inertia, could improve the perception of pain, functionality and quality of life in patients with hip and/or knee osteoarthritis (OA).
Ethics approval
The Ethical Committee of Hospital Universitario 12 de Octubre approved on August 1st, 2007. Notification was sent to the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) on November 20th, 2007.
Study design
Multicentre prospective cluster randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Hip and Knee Arthritis
Intervention
Clusters of primary care physicians working at the same healthcare centre for more than 6 months were randomly assigned to 1 of 2 study groups.
1. Group 1 (Proactive Intervention): Physicians in this group received a 45-60 minute training session on the latest European League Against Rheumatism (EULAR) recommendations on OA management, therapeutic goals, motivational techniques, and the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities (WOMAC) and Short Form-12 (SF-12) questionnaires.
2. Group 2 (Control): Physicians in this group received only a brief description of the study.
Each physician includes the first three patients with knee and/or hip OA who fulfil the eligibility criteria. Both groups were given the same Case Report Forms. All patients were scheduled for two visits (Visit 1 and Visit 2), six-months apart, during which a complete medical evaluation was carried out and VAS, WOMAC and SF-12 questionnaires were completed.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Evaluation of the clinical benefit of an educational intervention for primary care physicians, proposing a proactive approach to care (defined as a focus on updated treatment recommendations) in patients with arthritis. The primary outcome was measured by comparing results from visit 1 with those of visit 2.
Secondary outcome measures
1. Clinical characteristics, and progression of pain and functional capacity, in patients with knee and/or hip OA in Primary Care practice
2. identification of additional factors related with clinical inertia that, when modified, could result in clinical benefit for the patient
3. Description of characteristics of usual clinical practice carried out by primary care physicians
Overall trial start date
01/10/2007
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Physicians:
1. Belong to reselected Primary Care health centre
2. Have a daily clinical activity
3. Able to demonstrate a permanency up to 9 months in a clinical job
4. Commitment to follow all study criteria and recommendations
Patients:
1. Known diagnosis of hip and/or knee osteoarthritis fulfilling American College of Rheumatology (ACR) criteria.
2. Selected by physician (study subject) and gives informed consent to participate in this trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,925 Primary Care Physicians
Participant exclusion criteria
Physicians:
1. Unable to ensure job stability at Primary Care health centre over 9 months
2. Does not accept study criteria and recommendations
3. Already involved in improvement effort programs regarding clinical support for patients affected by joint disease
Patients:
1. Clinical antecedents of actual arthritic disease with prosthesis implanted
2. Arthritic disease involving exclusively or predominantly the spine (all locations) or upper limbs
3. Severe concomitant pathology with a short term life expectancy
4. Existence of non-arthritic rheumatic condition (fibromyalgia, rheumatoid arthritis, psoriasis, collagen diseases)
5. Psychological or sensorial impairment that prevents study participation
6. Existence of any absolute contraindication for anti-arthritic medications (Non-Steroidal Anti-Inflammatory Drugs [NSAIDs], etc.)
7. Does not wish to participate
8. Potential surgical intervention (next 6 months)
9. Additionally, any patients considered by his/her physician to be clinically inappropriate for participation and clinical data collection in this study
Recruitment start date
01/10/2007
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Sponsor information
Organisation
Spanish Society of Family Medicine and Community (Sociedad Española de Medicina de Familia y Comunitaria [SEMFYC]) (Spain)
Sponsor details
Portaferrissa
8
Barcelona
08002
Spain
+93 (0)317 0333
semfyc@semfyc.es
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Merck, Sharp & Dohme de España S.A. (Spain) - educational grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Family and Community Spanish Medical Society (SEMFyC) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list