Efficacy of a Didactic Intervention in Anticoagulated Patients (TAOPE Study)

Summary

Background: Oral anticoagulant drugs represent an essential tool in thrombo-embolic events prevention. Most used are vitamin K antagonists (VKA), which plasma level is monitored measuring prothrombin time using the International Normalized Ratio. If it takes values out of recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous researches have shown that, at best, only 33% of total patients keep values on therapeutic level.

The investigators intend to improve International Normalized Ratio control figures by a joint didactic intervention based on Junta de Andalucía School for Patients method that will be practiced by anticoagulated patients themselves.

Methods: A randomized clinical trial was carried out at primary care centers from one healthcare area in Malaga (Andalusia, Spain). Study population: patients included on oral anticoagulant therapy program using vitamin K antagonists.

First step: detection of patients on oral anticoagulation program with International Normalized Ratio on therapeutic level during 65% or less over total time. Second step: patients with inappropriate International Normalized Ratio control were practiced a joint didactic intervention "from peer to peer", by a previously trained and expert anticoagulated patient.

Study variables: time on therapeutic levels before and after intervention, sociodemographic variables, vital signs, existence of cardiovascular risk factors, basic blood test, other prescribed drugs, accompanying diseases and social support.

Almost-experimental analytic study with before-after statistical analysis of the intervention. Lineal regression models were applied on main variables results (International Normalized Ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases and social support.

Conditions

• Health Education
• Patient Education as Topic
• Blood Coagulation Tests

Interventions

BEHAVIORAL

Patient education group

Group meetings with educational sessions will be organised in health center. A group educational intervention was practiced to half of the patients, by one expert patient, so that every patient must attend to one group meeting

Sponsors & Collaborators

• Andaluz Health Service

  collaborator OTHER_GOV

• Francisco Javier Navarro Moya

  lead OTHER_GOV

Principal Investigators

• Francisco J Navarro Moya, Enfermera · Servicio de salud pública de Andalucía. Málaga, España

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2020-12-31

Completion

2021-09-01

Countries

• Spain

Study Locations