NCT03647254: TAOPE

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

Status unknown NA Last updated 27 September 2018

What this trial tests

NA trial testing Patient education group in Health Education in 1 participant. Status unknown.

Timeline

1 September 2018

Primary endpoint
31 December 2020

1 September 2021

Quick facts

Lead sponsor	Francisco Javier Navarro Moya
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	1
Start date	1 September 2018
Primary completion	31 December 2020
Estimated completion	1 September 2021
Sites	1 location across Spain

Drugs / interventions tested

• Patient education group

Conditions studied

• Health Education — all drugs for Health Education →
• Patient Education as Topic — all drugs for Patient Education as Topic →
• Blood Coagulation Tests — all drugs for Blood Coagulation Tests →

Sponsor

Francisco Javier Navarro Moya

Who can join

18 and older, any sex, with Health Education or Patient Education as Topic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial.
   Ginel-Mendoza L, Hidalgo-Natera A, Reina-Gonzalez R, Poyato-Ramos R, et al · · 2021 · cited 1× · PMID 33430922 · DOI 10.1186/s13063-020-04972-1