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Ischemic Heart DiseasePROPRESENCT01826929

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

A study testing Therapeutic education in people with Ischemic Heart Disease, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Ischemic Heart Disease
What is being tested?
Therapeutic education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesSpain
Study dates
Jan 2013to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Domingo Orozco-Beltran contact

0034 965919309

dorozcobeltran@hotmai.com

Spain3 sites, 3 recruiting

  • Study site

    Castellon, Castellon

    Enrique Soler-Bahilo

    Recruiting

  • Study site

    Sant Joan d'Alacant, Alicante

    Domingo Orozco-Beltran, 0034965919309, dorozcobeltran@gmail.com

    Domingo Orozco-Beltran

    Recruiting

  • Study site

    Valencia, Valencia

    Jorge Navarro-Perez

    Recruiting

Other trials in Spain

About this study

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.

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.

Being tested
Therapeutic education
Keywords
Health Services Research, Cardiovascular Diseases, Primary Care, Secondary Prevention.
Medical subject headings
Myocardial Ischemia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic educationOther

Study groups in NCT01826929
Study groupRoleWhat they receive
Therapeutic educationExperimentalOrganized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.
Receives: Other: Therapeutic education
Usual care modelNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Number of hospitalizations/cause at 12 months

    Measured: Baseline and 12 months

Secondary outcomes (6)

  1. Change from baseline Blood pressure

    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.

    Measured: Baseline, 4 months, 8 months and 12 months.

  2. Change from baseline LDL cholesterol

    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.

    Measured: Baseline, 4 months, 8 months and 12 months.

  3. Change from baseline Body Mass Index

    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.

    Measured: Baseline, 4 months, 8 months and 12 months

  4. Change from baseline Basal Blood Glucose

    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.

    Measured: Baseline, 4 months, 8 months and 12 months

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

    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.

    Measured: Baseline, 4 months, 8 months and 12 months

  6. Change from baseline Number of annual primary care visits

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826929
Sponsor's protocol ID
USI-10-66
Other IDs
SM I 14/2010
Acronym
PROPRESE
Status last verified
Apr 2013
First submitted
25 Mar 2013
Last updated
10 Apr 2013
Results posted
No
Data monitoring committee
No

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.

    PubMed 19091933

  • Banegas JR, Rodriguez-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. doi: 10.1038/sj.ejcn.1601804.

    PubMed 12947446

  • 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. doi: 10.1093/eurheartj/ehm316. Epub 2007 Aug 28. No abstract available.

    PubMed 17726041

  • 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.

    PubMed 19635253

  • 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.

    PubMed 22747998

  • Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala 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.

    PubMed 19286092

  • 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.

    PubMed 12509367

  • 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.

    PubMed 12377092

  • 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.

    PubMed 22529761

  • 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.

    PubMed 17261336

  • 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.

    PubMed 16230314

  • 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.

    PubMed 18361907

  • Brotons C, Soriano N, Moral I, Rodrigo MP, Kloppe P, Rodriguez AI, Gonzalez ML, Arino D, Orozco D, Buitrago F, Pepio JM, Borras 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.

    PubMed 21194823

  • 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.

    PubMed 19875426

  • 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.

    PubMed 18373926

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic education in people with Ischemic Heart Disease, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Domingo Orozco-Beltran (0034 965919309, dorozcobeltran@hotmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Number of hospitalizations/cause at 12 months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01826929, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.

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