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

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ClinicalTrials.gov Identifier: NCT03647254
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Andaluz Health Service
Information provided by (Responsible Party):
Francisco Javier Navarro Moya, Andaluz Health Service

Brief 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.


Condition or disease Intervention/treatment Phase
Health Education Patient Education as Topic Blood Coagulation Tests Behavioral: Patient education group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectivity of a Joint Didactic Intervention by School for Patients on Inappropriate Control Prothrombin Time Anticoagulated Patients. Protocol for Developing a Randomized and Controlled Clinical Trial
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Patient Education Group
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 and they continued with their usual controls
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
Other Name: Control group

No Intervention: Control group
Control group performed usual clinical practice, that is, people will be schedule by nurses about one time per month, except cases in which controls are inappropriate.



Primary Outcome Measures :
  1. Time on INR therapeutic levels in the last six months receiving VKA treatment [ Time Frame: Six months ]
    Appropriate INR level control will be assessed in two ways: measuring the therapeutic INR values percentages or Time percentages in therapeutic values estimated using Rosendaal method


Secondary Outcome Measures :
  1. Sociodemographic [ Time Frame: Six months ]
    Record of age and sex.

  2. Body mass index (BMI) [ Time Frame: 0 and 12 months. ]
    Determination of the body mass index calculated as the weight measured in kilograms (kg) divided by the height measured in meters squared (weight / height2) (Kg /m2).

  3. Diastolic and systolic blood pressure [ Time Frame: 0 and 12 months. ]
    Determination of diastolic and systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

  4. Heart rate [ Time Frame: 0 and 12 months. ]
    Determination of the number of heart beats per minute, average of 2 Determination of

  5. Smoking habit [ Time Frame: 0 and 12 months. ]
    Incidence of smoker's habit status in the electronic medical record.

  6. diabetes [ Time Frame: 0 and 12 months. ]
    Incidence of the condition of diabetes in the electronic medical record.

  7. Arterial hypertension [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of hypertension in the electronic medical record.

  8. Dyslipidemia [ Time Frame: 0 and 12 months. ]
    Incidence of the diagnosis of dyslipidemia in the electronic medical record.

  9. Chronic renal failure [ Time Frame: 0 and 12 months. ]
    Incidence of the diagnosis of chronic renal failure in the electronic medical record.

  10. Atrial fibrillation [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of atrial fibrillation in the electronic medical records of patients.

  11. Interventional cardiac valve diseases with or without atrial fibrillation [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of interventional cardiac valve diseases in the electronic medical records of patients.

  12. Ischemic cardiopathy [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of Ischemic cardiopathy in the electronic medical records of patients.

  13. Thromboembolic diseases history (stroke, transient ischemic attack) [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of thromboembolic diseases history (stroke, transient ischemic attack) in the electronic medical records of patients.

  14. Hemorrhagic stroke [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of hemorrhagic stroke in the electronic medical records of patients.

  15. Congestive heart failure [ Time Frame: 0 and 12 months. ]
    Incidence of diagnosis of congestive heart failure in the electronic medical records of patients.

  16. Glomerular filtration rates [ Time Frame: 0 and 12 months. ]
    Determination of total Glomerular filtration rates in mL/min/1,73 m2. Change of basal to 12 months.

  17. Total cholesterol [ Time Frame: 0 and 12 months. ]
    Determination of total cholesterol measured in milligrams per deciliter (mg/dl). Change of basal to 12 months.

  18. HDL Cholesterol [ Time Frame: 0 and 12 months. ]
    Determination of HDLc (high-density lipoprotein colesterol). LDLc measured in milligrams per deciliter (mg/dl)., (low-density lipoprotein colesterol). HDLc measured in milligrams per deciliter (mg/dl). Change of basal to 12 months.

  19. LDL cholesterol [ Time Frame: 0 and 12 months. ]
    Determination of LDLc (low-density lipoprotein colesterol). LDLc measured in milligrams per deciliter (mg/dl). Change of basal to 12 months.

  20. Triglycerides [ Time Frame: 0 and 12 months. ]
    Determination of total triglycerides measured in milligrams per deciliter (mg/dl). Change of basal to 12 months.

  21. Total number of drugs [ Time Frame: 0 and 12 months. ]
    Determination of the total number of different medications prescribed in the electronic medical records of patients. Change of basal to 12 months

  22. Anticoagulant type [ Time Frame: 0 and 12 months. ]
    Determination of the anticoagulant type prescribed in the electronic medical records of patients. Change at baseline and at 12 months.

  23. Consumption of "gastric protector" [ Time Frame: 0 and 12 months. ]
    Determination of the Consumption of "gastric protector" prescribed in the electronic medical records of patients. Change at baseline and at 12 months.

  24. Usual consumption of food rich in vitamin K [ Time Frame: 0 and 12 months. ]
    Change in usual consumption of food rich in vitamin K. Change at baseline and at 12 months

  25. Alcohol consumption [ Time Frame: 0 and 12 months. ]
    Change in usual Alcohol consumption. Change at baseline and at 12 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients on VKA treatment for at least the last six months in primary care environment.
  • Patients on inappropriate INR level control.
  • Patients in whom we have access to, at least, 80% of their INR levels. controls in last six months of treatment with VKA, although they are enrolled in another primary care center.
  • Patients who have given written informed consent to take part in the study

Exclusion Criteria:

  • Patients suffering from cognitive impairment wich prevents understanding what was written in the information sheet and informed consent.
  • Limited mobility patients, terminal patients, alcoholism or drug addiction, severe psychiatric illness or any other reason which makes patients to be present at center´s meetings imposible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647254


Contacts
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Contact: Francisco J Navarro Moya, Enfermera 34951031325 ext 768238 fjavier.navarro.sspa@juntadeandalucia.es
Contact: Leovigildo Ginel Mendoza, Médico 34659760079 ext 34951031325 lginel@gmail.com

Locations
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Spain
Distrito Sanitario Málaga. Servicio Andaluz de Salud Recruiting
Málaga, Spain, 29009
Contact: Francisco Javier Navarro-Moya, Nurse    +34951031325    fjavier.navarro.sspa@juntadeandalucia.es   
Contact: , Doctor         
Principal Investigator: Leovigildo Ginel Mendoza, Médico         
Sub-Investigator: Inmaculada Lupiañez, Enfermera         
Sponsors and Collaborators
Francisco Javier Navarro Moya
Andaluz Health Service
Investigators
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Study Chair: Francisco J Navarro Moya, Enfermera Servicio de salud pública de Andalucía. Málaga, España

Additional Information:
Publications:
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126.

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Responsible Party: Francisco Javier Navarro Moya, Effectiveness and Research Unit Coordinator. District of Malaga. Andalusian Health Service. Spain, Andaluz Health Service
ClinicalTrials.gov Identifier: NCT03647254     History of Changes
Other Study ID Numbers: AndaluzHS
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francisco Javier Navarro Moya, Andaluz Health Service:
Anticoagulants
Warfarin