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

NCT03647254 | Unknown

• 1 other identifier: AndaluzHS
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Education; Patient Education as Topic; Blood Coagulation Tests

Keywords

Anticoagulants; Warfarin

Outcome Measures

Primary Outcomes (1)

• Time on INR therapeutic levels in the last six months receiving VKA treatment

  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

  Six months

Secondary Outcomes (25)

• Sociodemographic

  Six months

• Body mass index (BMI)

  0 and 12 months.

• Diastolic and systolic blood pressure

  0 and 12 months.

• Heart rate

  0 and 12 months.

• Smoking habit

  0 and 12 months.

Study Arms (2)

Patient Education Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Patient education group BEHAVIORAL

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

Also known as: Control group

Patient Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Javier Navarro Moya: lead
• Andaluz Health Service: collaborator

Study Sites (1)

Distrito Sanitario Málaga. Servicio Andaluz de Salud

Málaga, 29009, Spain

RECRUITING

Related Publications (26)

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  PMID: 22315269 BACKGROUND

• Oden A, Fahlen M, Hart RG. Optimal INR for prevention of stroke and death in atrial fibrillation: a critical appraisal. Thromb Res. 2006;117(5):493-9. doi: 10.1016/j.thromres.2004.11.025. Epub 2004 Dec 25.

  PMID: 16517250 BACKGROUND

• Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.

  PMID: 17577005 BACKGROUND

• Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008 Nov;1(2):84-91. doi: 10.1161/CIRCOUTCOMES.108.796185. Epub 2008 Nov 5.

  PMID: 20031794 BACKGROUND

• 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, Syvanne 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. No abstract available.

  PMID: 22555213 BACKGROUND

• Wolowacz SE, Samuel M, Brennan VK, Jasso-Mosqueda JG, Van Gelder IC. The cost of illness of atrial fibrillation: a systematic review of the recent literature. Europace. 2011 Oct;13(10):1375-85. doi: 10.1093/europace/eur194. Epub 2011 Jul 14.

  PMID: 21757483 BACKGROUND

• Gomez-Doblas JJ, Muniz J, Martin JJ, Rodriguez-Roca G, Lobos JM, Awamleh P, Permanyer-Miralda G, Chorro FJ, Anguita M, Roig E; OFRECE study collaborators. Prevalence of atrial fibrillation in Spain. OFRECE study results. Rev Esp Cardiol (Engl Ed). 2014 Apr;67(4):259-69. doi: 10.1016/j.rec.2013.07.014. Epub 2013 Nov 25.

  PMID: 24774588 BACKGROUND

• Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009 Dec 1;104(11):1534-9. doi: 10.1016/j.amjcard.2009.07.022.

  PMID: 19932788 BACKGROUND

• Robert-Ebadi H, Le Gal G, Righini M. Use of anticoagulants in elderly patients: practical recommendations. Clin Interv Aging. 2009;4:165-77. doi: 10.2147/cia.s4308. Epub 2009 May 14.

  PMID: 19503778 BACKGROUND

• Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.

  PMID: 19762550 BACKGROUND

• Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011 Jan 31;342:d124. doi: 10.1136/bmj.d124.

  PMID: 21282258 BACKGROUND

• European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.

  PMID: 20802247 BACKGROUND

• Steinberg BA, Piccini JP. Anticoagulation in atrial fibrillation. BMJ. 2014 Apr 14;348:g2116. doi: 10.1136/bmj.g2116.

  PMID: 24733535 BACKGROUND

• Riley RS, Rowe D, Fisher LM. Clinical utilization of the international normalized ratio (INR). J Clin Lab Anal. 2000;14(3):101-14. doi: 10.1002/(sici)1098-2825(2000)14:33.0.co;2-a.

  PMID: 10797608 BACKGROUND

• Cardenas Valladolid J, Mena Mateo J, Canada Dorado MM, Rodriguez Morales D, Sanchez Perruca L. [Implementation and improvement in a care program for the elderly on multiple medications in a primary care area]. Rev Calid Asist. 2009 Feb;24(1):24-31. doi: 10.1016/S1134-282X(09)70072-7. Epub 2009 Feb 23. Spanish.

  PMID: 19369139 BACKGROUND

• Clarkesmith DE, Pattison HM, Lane DA. Educational and behavioural interventions for anticoagulant therapy in patients with atrial fibrillation. Cochrane Database Syst Rev. 2013 Jun 4;(6):CD008600. doi: 10.1002/14651858.CD008600.pub2.

  PMID: 23736948 BACKGROUND

• Lobos-Bejarano JM, del Castillo-Rodriguez JC, Mena-Gonzalez A, Aleman-Sanchez JJ, Cabrera de Leon A, Baron-Esquivias G, Pastor-Fuentes A; en nombre de los Investigadores del Estudio FIATE (Situacion actual de la FIbrilacion auricular en ATencion primaria en Espana). [Patients' characteristics and clinical management of atrial fibrillation in primary healthcare in Spain: FIATE Study]. Med Clin (Barc). 2013 Oct 5;141(7):279-86. doi: 10.1016/j.medcli.2012.12.023. Epub 2013 May 15. Spanish.

  PMID: 23683967 BACKGROUND

• Gallagher AM, Setakis E, Plumb JM, Clemens A, van Staa TP. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost. 2011 Nov;106(5):968-77. doi: 10.1160/TH11-05-0353. Epub 2011 Sep 8.

  PMID: 21901239 BACKGROUND

• Han SY, Palmeri ST, Broderick SH, Hasselblad V, Rendall D, Stevens S, Tenaglia A, Velazquez E, Whellan D, Wagner G, Heitner JF. Quality of anticoagulation with warfarin in patients with nonvalvular atrial fibrillation in the community setting. J Electrocardiol. 2013 Jan-Feb;46(1):45-50. doi: 10.1016/j.jelectrocard.2012.08.011. Epub 2012 Oct 11.

  PMID: 23063241 BACKGROUND

• Barrios V, Escobar C, Prieto L, Osorio G, Polo J, Lobos JM, Vargas D, Garcia N. Anticoagulation Control in Patients With Nonvalvular Atrial Fibrillation Attended at Primary Care Centers in Spain: The PAULA Study. Rev Esp Cardiol (Engl Ed). 2015 Sep;68(9):769-76. doi: 10.1016/j.rec.2015.04.017. Epub 2015 Jul 11.

  PMID: 26169326 BACKGROUND

• Cinza Sanjurjo S, Rey Aldana D, Gestal Pereira E, Calvo Gomez C; ANFAGAL (ANticoagulacion en pacientes con Fibrilacion Auricular en ambito de atencion primaria de GALicia) study. Degree of Anticoagulation Control in Patients With Atrial Fibrillation in Spain: Need to Minimize Biases and Contextualize Results. Response by Cinza Sanjurjo et al. Rev Esp Cardiol (Engl Ed). 2016 Mar;69(3):357-8. doi: 10.1016/j.rec.2015.12.005. Epub 2016 Jan 30. No abstract available.

  PMID: 26839056 BACKGROUND

• Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost. 1993 Mar 1;69(3):236-9.

  PMID: 8470047 BACKGROUND

• Anguita Sanchez M, Bertomeu Martinez V, Cequier Fillat A; CALIFA study researchers. Quality of Vitamin K Antagonist Anticoagulation in Spain: Prevalence of Poor Control and Associated Factors. Rev Esp Cardiol (Engl Ed). 2015 Sep;68(9):761-8. doi: 10.1016/j.rec.2014.11.019. Epub 2015 Mar 23.

  PMID: 25814183 BACKGROUND

• Richards T, Montori VM, Godlee F, Lapsley P, Paul D. Let the patient revolution begin. BMJ. 2013 May 14;346:f2614. doi: 10.1136/bmj.f2614. No abstract available.

  PMID: 23674136 BACKGROUND

• Nuno-Solinis R, Rodriguez-Pereira C, Pinera-Elorriaga K, Zaballa-Gonzalez I, Bikandi-Irazabal J. [Panorama of self-management initiatives in Spain]. Gac Sanit. 2013 Jul-Aug;27(4):332-7. doi: 10.1016/j.gaceta.2013.01.008. Epub 2013 Mar 5. Spanish.

  PMID: 23465729 BACKGROUND

• Ginel-Mendoza L, Hidalgo-Natera A, Reina-Gonzalez R, Poyato-Ramos R, Morales-Naranjo J, Lupianez-Perez I, Baca-Osorio A, Gutierrez-Jansen M, Fernandez-Lara MP, Lozano-Noriega D, Salgado-Carvallo U, Bandera-Garcia C, Navarro-Moya FJ. Efficacy of a joint didactic intervention using the Junta De Andalucia School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial. Trials. 2021 Jan 11;22(1):45. doi: 10.1186/s13063-020-04972-1.

  PMID: 33430922 DERIVED

Related Links

• Registered follow-up of individualized pharmacological treatment in patients with oral anticoagulation

MeSH Terms

Conditions

Health Education

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Francisco J Navarro Moya, Enfermera

  Servicio de salud pública de Andalucía. Málaga, España

  STUDY CHAIR

Central Study Contacts

Francisco J Navarro Moya, Enfermera

CONTACT

34951031325; fjavier.navarro.sspa@juntadeandalucia.es

Leovigildo Ginel Mendoza, Médico

CONTACT

34659760079; lginel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Effectiveness and Research Unit Coordinator. District of Malaga. Andalusian Health Service. Spain

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 27, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 1, 2021
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

ES (1)