Condition category
Musculoskeletal Diseases
Date applied
04/02/2010
Date assigned
19/02/2010
Last edited
22/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes