Health Education Clinical Trial
— TAOPEOfficial 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
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.
Status | Recruiting |
Enrollment | 1 |
Est. completion date | September 1, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Málaga |
Lead Sponsor | Collaborator |
---|---|
Francisco Javier Navarro Moya | Andaluz Health Service |
Spain,
Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e44S-e88S. doi: 10.1378/chest.11-2292. Review. — View Citation
Anguita Sánchez M, Bertomeu Martínez V, Cequier Fillat Á; 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. — View Citation
Barrios V, Escobar C, Prieto L, Osorio G, Polo J, Lobos JM, Vargas D, García 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. — View Citation
Cárdenas Valladolid J, Mena Mateo J, Cañada Dorado MM, Rodríguez Morales D, Sánchez 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. — View Citation
Cinza Sanjurjo S, Rey Aldana D, Gestal Pereira E, Calvo Gómez C; ANFAGAL (ANticoagulación en pacientes con Fibrilación Auricular en ámbito de atención 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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 05;4:CD008600. — View Citation
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. Erratum in: Eur Heart J. 2011 May;32(9):1172. — View Citation
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. — View Citation
Gómez-Doblas JJ, Muñiz J, Martin JJ, Rodríguez-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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Lobos-Bejarano JM, del Castillo-Rodríguez JC, Mena-González A, Alemán-Sánchez JJ, Cabrera de León A, Barón-Esquivias G, Pastor-Fuentes A; en nombre de los Investigadores del Estudio FIATE (Situación actual de la FIbrilación auricular en ATención primaria en España). [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. — View Citation
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. — View Citation
Nuño-Solinis R, Rodríguez-Pereira C, Piñera-Elorriaga K, Zaballa-González 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. — View Citation
Odén A, Fahlén M, Hart RG. Optimal INR for prevention of stroke and death in atrial fibrillation: a critical appraisal. Thromb Res. 2006;117(5):493-9. Epub 2004 Dec 25. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Riley RS, Rowe D, Fisher LM. Clinical utilization of the international normalized ratio (INR). J Clin Lab Anal. 2000;14(3):101-14. Review. — View Citation
Robert-Ebadi H, Le Gal G, Righini M. Use of anticoagulants in elderly patients: practical recommendations. Clin Interv Aging. 2009;4:165-77. Epub 2009 May 14. Review. — View Citation
Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost. 1993 Mar 1;69(3):236-9. — View Citation
Steinberg BA, Piccini JP. Anticoagulation in atrial fibrillation. BMJ. 2014 Apr 14;348:g2116. doi: 10.1136/bmj.g2116. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sociodemographic | Record of age and sex. | Six months | |
Secondary | Body mass index (BMI) | 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). | 0 and 12 months. | |
Secondary | Diastolic and systolic blood pressure | Determination of diastolic and systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations. | 0 and 12 months. | |
Secondary | Heart rate | Determination of the number of heart beats per minute, average of 2 Determination of | 0 and 12 months. | |
Secondary | Smoking habit | Incidence of smoker's habit status in the electronic medical record. | 0 and 12 months. | |
Secondary | diabetes | Incidence of the condition of diabetes in the electronic medical record. | 0 and 12 months. | |
Secondary | Arterial hypertension | Incidence of diagnosis of hypertension in the electronic medical record. | 0 and 12 months. | |
Secondary | Dyslipidemia | Incidence of the diagnosis of dyslipidemia in the electronic medical record. | 0 and 12 months. | |
Secondary | Chronic renal failure | Incidence of the diagnosis of chronic renal failure in the electronic medical record. | 0 and 12 months. | |
Secondary | Atrial fibrillation | Incidence of diagnosis of atrial fibrillation in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Interventional cardiac valve diseases with or without atrial fibrillation | Incidence of diagnosis of interventional cardiac valve diseases in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Ischemic cardiopathy | Incidence of diagnosis of Ischemic cardiopathy in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Thromboembolic diseases history (stroke, transient ischemic attack) | Incidence of diagnosis of thromboembolic diseases history (stroke, transient ischemic attack) in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Hemorrhagic stroke | Incidence of diagnosis of hemorrhagic stroke in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Congestive heart failure | Incidence of diagnosis of congestive heart failure in the electronic medical records of patients. | 0 and 12 months. | |
Secondary | Glomerular filtration rates | Determination of total Glomerular filtration rates in mL/min/1,73 m2. Change of basal to 12 months. | 0 and 12 months. | |
Secondary | Total cholesterol | Determination of total cholesterol measured in milligrams per deciliter (mg/dl). Change of basal to 12 months. | 0 and 12 months. | |
Secondary | HDL Cholesterol | 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. | 0 and 12 months. | |
Secondary | LDL cholesterol | Determination of LDLc (low-density lipoprotein colesterol). LDLc measured in milligrams per deciliter (mg/dl). Change of basal to 12 months. | 0 and 12 months. | |
Secondary | Triglycerides | Determination of total triglycerides measured in milligrams per deciliter (mg/dl). Change of basal to 12 months. | 0 and 12 months. | |
Secondary | Total number of drugs | Determination of the total number of different medications prescribed in the electronic medical records of patients. Change of basal to 12 months | 0 and 12 months. | |
Secondary | Anticoagulant type | Determination of the anticoagulant type prescribed in the electronic medical records of patients. Change at baseline and at 12 months. | 0 and 12 months. | |
Secondary | Consumption of "gastric protector" | Determination of the Consumption of "gastric protector" prescribed in the electronic medical records of patients. Change at baseline and at 12 months. | 0 and 12 months. | |
Secondary | Usual consumption of food rich in vitamin K | Change in usual consumption of food rich in vitamin K. Change at baseline and at 12 months | 0 and 12 months. | |
Secondary | Alcohol consumption | Change in usual Alcohol consumption. Change at baseline and at 12 months | 0 and 12 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03303287 -
School Health Education Program in Pakistan(SHEPP)
|
N/A | |
Completed |
NCT03989401 -
Effect of Multi-media Health Education on Nurses' Workload and Patient's Satisfaction
|
N/A | |
Not yet recruiting |
NCT05031377 -
Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD
|
N/A | |
Completed |
NCT05526365 -
Idea Density in Exam Performance
|
N/A | |
Completed |
NCT02591511 -
Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT04914871 -
Readiness for Basic Life Support in Schools
|
N/A | |
Completed |
NCT04568785 -
Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
|
N/A | |
Completed |
NCT03125668 -
Impact of Telephone Follow-up in Patient's Health-related Quality of Life That Use Warfarin
|
N/A | |
Not yet recruiting |
NCT02938676 -
Satisfaction Degree in a Nurse Educational Program to Heart Transplant Patient
|
N/A | |
Not yet recruiting |
NCT06350344 -
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
|
N/A | |
Not yet recruiting |
NCT04876885 -
The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
|
N/A | |
Not yet recruiting |
NCT03953911 -
Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
|
Early Phase 1 | |
Not yet recruiting |
NCT06392035 -
Breakfast Training Based on PENDER's Health Promotion Model (HPM)
|
N/A | |
Completed |
NCT05244876 -
Effect of Back School-based Intervention on Non-specific Neck Pain in Adults.
|
N/A | |
Not yet recruiting |
NCT06350331 -
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
|
N/A | |
Completed |
NCT04530331 -
Job-Site Diet Education on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT06266845 -
Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients
|
N/A | |
Completed |
NCT03447119 -
Living Well With a Disability Curriculum Adaptation Evaluation Plan
|
N/A | |
Not yet recruiting |
NCT04741867 -
The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress
|
N/A | |
Completed |
NCT05260645 -
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
|
N/A |