NCT01826929

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

March 25, 2013

Last Update Submit

April 9, 2013

Conditions

Ischemic Heart Disease

Keywords

Health Services ResearchCardiovascular DiseasesPrimary CareSecondary Prevention.

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Number of hospitalizations/cause at 12 months

    Baseline and 12 months

Secondary Outcomes (6)

  • Change from baseline Blood pressure

    Baseline, 4 months, 8 months and 12 months.

  • Change from baseline LDL cholesterol

    Baseline, 4 months, 8 months and 12 months.

  • Change from baseline Body Mass Index

    Baseline, 4 months, 8 months and 12 months

  • Change from baseline Basal Blood Glucose

    Baseline, 4 months, 8 months and 12 months

  • Change from baseline Healthy Life Habits (exercise, mediterranean diet)

    Baseline, 4 months, 8 months and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Therapeutic education

EXPERIMENTAL

Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.

Other: Therapeutic education

Usual care model

NO INTERVENTION

Interventions

Therapeutic educationOTHER
Therapeutic education

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • lack of consent
  • immobilized patients
  • patients with serious health problems or with a low life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Sant Joan d'Alacant, Alicante, Spain

RECRUITING

Unknown Facility

Castellon, Castellon, Spain

RECRUITING

Unknown Facility

Valencia, Valencia, Spain

RECRUITING

Related Publications (21)

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    PMID: 17726041BACKGROUND

  • Lobos JM, Royo-Bordonada MA, Brotons C, Alvarez-Sala L, Armario P, Maiques A, Mauricio D, Sans S, Villar F, Lizcano A, Gil-Nunez A, de Alvaro F, Conthe P, Luengo E, Del Rio A, Cortes O, de Santiago A, Varga MA, Martinez M, Lizarbe V; Comite Espanol Interdisciplinario para la Prevencion Cardiovascular. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. CEIPC 2008 Spanish adaptation]. Rev Clin Esp. 2009 Jun;209(6):279-302. Spanish.

    PMID: 19635253BACKGROUND

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    PMID: 22747998BACKGROUND

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    PMID: 19286092BACKGROUND

  • 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. doi: 10.1093/fampra/20.1.32.

    PMID: 12509367BACKGROUND

  • 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. doi: 10.1001/jama.288.15.1909.

    PMID: 12377092BACKGROUND

  • 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. doi: 10.7812/TPP/11-134.

    PMID: 22529761BACKGROUND

  • Munoz MA, Vila J, Cabanero M, Rebato C, Subirana I, Sala J, Marrugat J; ICAR (Intervencion 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. doi: 10.1016/j.ijcard.2006.07.015. Epub 2007 Jan 29.

    PMID: 17261336BACKGROUND

  • Munoz MA, Rohlfs I, Masuet S, Rebato C, Cabanero 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. doi: 10.1093/eurpub/cki202. Epub 2005 Oct 17.

    PMID: 16230314BACKGROUND

  • Orozco-Beltran D, Brotons C, Moral I, Soriano N, Del Valle MA, Rodriguez AI, Pepio 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.

    PMID: 18361907BACKGROUND

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    PMID: 21194823BACKGROUND

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    PMID: 19875426BACKGROUND

  • Ortiz Tobarra MT, Orozco Beltran D, Gil Guillen V, Terol Molto C. [Frequency of attendance and degree of control of type-2 diabetic patients]. Aten Primaria. 2008 Mar;40(3):139-44. doi: 10.1157/13116629. Spanish.

    PMID: 18373926BACKGROUND

  • Mira JJ, Orozco-Beltran D, Perez-Jover V, Martinez-Jimeno L, Gil-Guillen VF, Carratala-Munuera C, Sanchez-Molla M, Pertusa-Martinez 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.

    PMID: 22904014BACKGROUND

  • Marquez-Contreras E, de la Figuera-Von Wichmann M, Franch-Nadal J, Llisterri-Caro JL, Gil-Guillen V, Martin-de Pablos JL, Casado-Martinez 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.

    PMID: 22520867BACKGROUND

  • Gil-Guillen V, Orozco-Beltran D, Marquez-Contreras E, Durazo-Arvizu R, Cooper R, Pita-Fernandez S, Gonzalez-Segura D, Carratala-Munuera C, Martin de Pablo JL, Pallares V, Pertusa-Martinez S, Fernandez A, Redon 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.

    PMID: 22117096BACKGROUND

  • Gil-Guillen V, Orozco-Beltran D, Perez RP, Alfonso JL, Redon J, Pertusa-Martinez S, Navarro J, Cea-Calvo L, Quirce-Andres F, Merino-Sanchez J, Carratala C, Martin-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.

    PMID: 19929287BACKGROUND

  • 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.

    PMID: 21309833BACKGROUND

  • Orozco-Beltran D, Ruescas-Escolano E, Navarro-Palazon AI, Cordero A, Gaubert-Tortosa M, Navarro-Perez J, Carratala-Munuera C, Pertusa-Martinez S, Soler-Bahilo E, Brotons-Munto F, Bort-Cubero J, Nunez-Martinez MA, Bertomeu-Martinez V, Gil-Guillen VF; PROPRESE research team. 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. BMC Health Serv Res. 2013 Aug 2;13:293. doi: 10.1186/1472-6963-13-293.

    PMID: 23915267DERIVED

MeSH Terms

Conditions

Myocardial IschemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesVascular Diseases

Central Study Contacts

Domingo Orozco-Beltran

CONTACT

0034 965919309dorozcobeltran@hotmai.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 9, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

ES(3)