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Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based (PROPRESE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826929
First Posted: April 9, 2013
Last Update Posted: April 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
  Purpose
The purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.

Condition Intervention
Ischemic Heart Disease Other: Therapeutic education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based on a Multifactorial Intervention: The PROPRESE Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:

Primary Outcome Measures:
  • Change from baseline Number of hospitalizations/cause at 12 months [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures:
  • Change from baseline Blood pressure [ Time Frame: Baseline, 4 months, 8 months and 12 months. ]
    It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.

  • Change from baseline LDL cholesterol [ Time Frame: Baseline, 4 months, 8 months and 12 months. ]
    It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.

  • Change from baseline Body Mass Index [ Time Frame: Baseline, 4 months, 8 months and 12 months ]
    It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.

  • Change from baseline Basal Blood Glucose [ Time Frame: Baseline, 4 months, 8 months and 12 months ]
    It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.

  • Change from baseline Healthy Life Habits (exercise, mediterranean diet) [ Time Frame: Baseline, 4 months, 8 months and 12 months ]
    It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.

  • Change from baseline Number of annual primary care visits [ Time Frame: Baseline and 12 months ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic education
Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.
Other: Therapeutic education
No Intervention: Usual care model

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a diagnosis of IHD of any site (ICD-10 codes from 410 to 414 inclusive.
  • signed written informed consent

Exclusion Criteria:

  • lack of consent
  • immobilized patients
  • patients with serious health problems or with a low life expectancy
  Contacts and Locations
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): NCT01826929


Contacts
Contact: Domingo Orozco-Beltran 0034 965919309 dorozcobeltran@hotmai.com

Locations
Spain
Recruiting
San Juan de Alicante, Alicante, Spain
Contact: Domingo Orozco-Beltran    0034965919309    dorozcobeltran@gmail.com   
Principal Investigator: Domingo Orozco-Beltran         
Recruiting
Castellon, Spain
Sub-Investigator: Enrique Soler-Bahilo         
Recruiting
Valencia, Spain
Sub-Investigator: Jorge Navarro-Perez         
Sponsors and Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
  More Information

Publications:
Lorig KR, Ritter PL, Dost A, Plant K, Laurent DD, McNeil I. The Expert Patients Programme online, a 1-year study of an Internet-based self-management programme for people with long-term conditions. Chronic Illn. 2008 Dec;4(4):247-56. doi: 10.1177/1742395308098886.
Banegas JR, Rodríguez-Artalejo F, Graciani A, Villar F, Herruzo R. Mortality attributable to cardiovascular risk factors in Spain. Eur J Clin Nutr. 2003 Sep;57 Suppl 1:S18-21.
Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Scholte op Reimer W, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A; European Society of Cardiology (ESC) Committee for Practice Guidelines (CPG). European guidelines on cardiovascular disease prevention in clinical practice: executive summary: Fourth 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. 2007 Oct;28(19):2375-414. Epub 2007 Aug 28.
Lobos JM, Royo-Bordonada MA, Brotons C, Alvarez-Sala L, Armario P, Maiques A, Mauricio D, Sans S, Villar F, Lizcano A, Gil-Núñez A, de Alvaro F, Conthe P, Luengo E, Del Río A, Cortés O, de Santiago A, Varga MA, Martínez M, Lizarbe V; Comité Español Interdisciplinario para la Prevención Cardiovascular. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. CEIPC 2008 Spanish adaptation]. Rev Clin Esp. 2009 Jun;209(6):279-302. Spanish.
Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.
Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5.
Brotons C, Permanyer G, Pacheco V, Moral I, Ribera A, Cascant P, Pinar J; PREMISE study group. Prophylactic treatment after myocardial infarction in primary care: how far can we go? Fam Pract. 2003 Feb;20(1):32-5.
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14.
Davino-Ramaya C, Krause LK, Robbins CW, Harris JS, Koster M, Chan W, Tom GI. Transparency matters: Kaiser Permanente's National Guideline Program methodological processes. Perm J. 2012 Winter;16(1):55-62. Review.
Munoz MA, Vila J, Cabañero M, Rebato C, Subirana I, Sala J, Marrugat J; ICAR (Intervención en la Comunidad de Alto Riesgo cardiovascular) investigators. Efficacy of an intensive prevention program in coronary patients in primary care, a randomised clinical trial. Int J Cardiol. 2007 Jun 12;118(3):312-20. Epub 2007 Jan 29.
Munoz MA, Rohlfs I, Masuet S, Rebato C, Cabañero M, Marrugat J; ICAR Study Group. Analysis of inequalities in secondary prevention of coronary heart disease in a universal coverage health care system. Eur J Public Health. 2006 Aug;16(4):361-7. Epub 2005 Oct 17.
Orozco-Beltrán D, Brotons C, Moral I, Soriano N, Del Valle MA, Rodríguez AI, Pepió JM, Pastor A; investigadores del estudio PREseAP. [Factors affecting the control of blood pressure and lipid levels in patients with cardiovascular disease: the PREseAP Study]. Rev Esp Cardiol. 2008 Mar;61(3):317-21. Spanish.
Brotons C, Soriano N, Moral I, Rodrigo MP, Kloppe P, Rodríguez AI, González ML, Ariño D, Orozco D, Buitrago F, Pepió JM, Borrás I; PREseAP study research team. Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study. Rev Esp Cardiol. 2011 Jan;64(1):13-20. doi: 10.1016/j.recesp.2010.07.005. Epub 2010 Dec 30. Erratum in: Rev Esp Cardiol. 2011 Jun;64(6):544.
Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J; SPHERE study team. Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. BMJ. 2009 Oct 29;339:b4220. doi: 10.1136/bmj.b4220.
Ortiz Tobarra MT, Orozco Beltrán D, Gil Guillén V, Terol Moltó C. [Frequency of attendance and degree of control of type-2 diabetic patients]. Aten Primaria. 2008 Mar;40(3):139-44. Spanish.
Mira JJ, Orozco-Beltrán D, Pérez-Jover V, Martínez-Jimeno L, Gil-Guillén VF, Carratala-Munuera C, Sánchez-Molla M, Pertusa-Martínez S, Asencio-Aznar A. Physician patient communication failure facilitates medication errors in older polymedicated patients with multiple comorbidities. Fam Pract. 2013 Feb;30(1):56-63. doi: 10.1093/fampra/cms046. Epub 2012 Aug 17.
Márquez-Contreras E, de la Figuera-Von Wichmann M, Franch-Nadal J, Llisterri-Caro JL, Gil-Guillén V, Martín-de Pablos JL, Casado-Martínez JJ, Martell-Claros N. Do Patients With High Vascular Risk Take Antihypertensive Medication Correctly? Cumple-MEMS Study. Rev Esp Cardiol (Engl Ed). 2012 Jun;65(6):544-50. doi: 10.1016/j.recesp.2012.01.018. Epub 2012 Apr 19.
Gil-Guillén V, Orozco-Beltrán D, Márquez-Contreras E, Durazo-Arvizu R, Cooper R, Pita-Fernández S, González-Segura D, Carratalá-Munuera C, Martín de Pablo JL, Pallarés V, Pertusa-Martínez S, Fernández A, Redón J. Is there a predictive profile for clinical inertia in hypertensive patients? An observational, cross-sectional, multicentre study. Drugs Aging. 2011 Dec 1;28(12):981-92. doi: 10.2165/11596640-000000000-00000.
Gil-Guillén V, Orozco-Beltrán D, Pérez RP, Alfonso JL, Redón J, Pertusa-Martínez S, Navarro J, Cea-Calvo L, Quirce-Andrés F, Merino-Sánchez J, Carratalá C, Martín-Moreno JM. Clinical inertia in diagnosis and treatment of hypertension in primary care: quantification and associated factors. Blood Press. 2010 Feb;19(1):3-10. doi: 10.3109/08037050903350762.
Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse-led interventions used to improve control of high blood pressure in people with diabetes: a systematic review and meta-analysis. Diabet Med. 2011 Mar;28(3):250-61. doi: 10.1111/j.1464-5491.2010.03204.x. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT01826929     History of Changes
Other Study ID Numbers: USI-10-66
SM I 14/2010 ( Other Grant/Funding Number: Valencia Regional Ministry of Health )
First Submitted: March 25, 2013
First Posted: April 9, 2013
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:
Health Services Research
Cardiovascular Diseases
Primary Care
Secondary Prevention.

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases


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