Influence of active awareness about venous thromboembolism relevance and rate of symptomatic deep vein thrombosis
| ISRCTN | ISRCTN27831914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27831914 |
| Secondary identifying numbers | DIREG L 03049 |
- Submission date
- 12/01/2012
- Registration date
- 31/01/2012
- Last edited
- 25/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Deep vein thrombosis (DVT) is a blood clot that develops within a deep vein in the body, usually in the leg, causing cause pain and swelling. The symptoms of DVT are not specific - patients can have large clots but only minimal symptoms which, if disregarded, can result in dangerous consequences including sudden death. However, most DVT patients have a good outcome. An increase in public awareness of DVT and its symptoms may in time reduce the overall disease burden. Although there have been many attempts to raise public awareness about DVT, their effects are not known. The aim of this study is to find out whether an increase in public awareness results in more people being correctly diagnosed with DVT.
Who can participate?
Patients aged over 18 with symptoms suggesting DVT
What does the study involve?
A campaign to raise public awareness of DVT is conducted in an urban area, with brochures being distributed four times during a year and posters and newsletter articles being published. This area is compared with another area that is not exposed to the campaign. Patients with symptoms of DVT in both areas are referred by their GPs for an ultrasound scan of their leg at no charge to the patient. The impact of the educational campaign on the number of patients correctly diagnosed DVT is assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Institute of Tuberculosis and Lung Diseases (Instytut Gruzlicy i Chorob Pluc) (Poland)
When is the study starting and how long is it expected to run for?
December 2007 to November 2009
Who is funding the study?
Sanofi-Aventis (Poland)
Who is the main contact?
Prof. Witold Tomkowski
Contact information
Scientific
Instytut Gruzlicy i Chorob Pluc
Plocka Str. 26
Warsaw
01-138
Poland
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Influence of Active awareness about Venous ThromboEmbolism relevance and Rate of Symptomatic deep vein thrombosis: an observational study |
| Study acronym | AVTERS |
| Study objectives | An increase in public awareness would result in an increase in the frequency of objectively confirmed deep vein thrombosis (DVT), wherever its anatomic location. |
| Ethics approval(s) | Bioethics Committee, National TB and Lung Diseases Research Institute, Warsaw, Poland, 19/11/2007, ref: KE-142/2007 |
| Health condition(s) or problem(s) studied | Deep vein thrombosis (DVT) |
| Intervention | A campaign to raise public awareness of DVT was conducted in an urban population cluster (A) of approximately 100,000 via distribution of brochures four times during a year and publishing posters and newsletter articles. A comparison urban population cluster (B) of approximately 1,574,000, was not exposed to this campaign. Patients symptomatic for DVT in both populations were referred by general practitioners for a standardized compression ultrasound (CUS) of the whole leg at no charge to the patient. Reports of positive CUS exams documented by photographs were analyzed by an independent adjudication committee blinded to the population cluster. Cluster A was followed for 8 months after the information campaign ended. |
| Intervention type | Other |
| Primary outcome measure | Evaluation of the impact of an educational campaign dedicated to thromboembolic complications on increased number of correctly diagnosed DVT |
| Secondary outcome measures | 1. Evaluation of the rate of correctly diagnosed DVT among the general population in Poland 2. Evaluation of the risk factors in patients with confirmed DVT 3. Evaluation of which diagnostic methods are applied to confirm DVT symptoms |
| Overall study start date | 01/12/2007 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Key inclusion criteria | 1. Male or female aged > 18 2. A patient with clinical symptoms suggesting thrombosis, referred by primary care physicians selected to the study 3. A patient with deep vein thrombosis confirmed with diagnostic methods 4. A patient with newly diagnosed deep vein thrombosis or with recurring thrombosis in a vein with existing thrombosis process |
| Key exclusion criteria | 1. Aged under 18 2. No signs or symptoms of deep vein thrombosis 3. No consent for participation in the study |
| Date of first enrolment | 01/12/2007 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Poland
Study participating centre
01-138
Poland
Sponsor information
Industry
Bonifraterska Str. 17
Warsaw
00-203
Poland
| Website | http://www.sanofi-aventis.pl/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/05/2017: Plain English summary added.
