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Study to Improve the Treatment of Patients With Heart Failure by General Practitioners (TOPHU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662323
First Posted: August 10, 2012
Last Update Posted: November 14, 2012
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.
Collaborator:
Agis Zorgverzekeringen
Information provided by (Responsible Party):
Drs. Mark M J Valk, Julius Center
  Purpose
The purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. After 6 month the investigators ask the patients to fill out a questionary. The investigators ask them about their quality of live.

Condition Intervention Phase
Heart Failure Behavioral: GP's treating HF according the dutch guidelines Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Therapy OPtimization Heart Failure Utrecht

Resource links provided by NLM:


Further study details as provided by Drs. Mark M J Valk, Julius Center:

Primary Outcome Measures:
  • proportion recommended medication for patients with heart failure [ Time Frame: up to 6 months ]
    the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.


Secondary Outcome Measures:
  • QoL [ Time Frame: up to 1 year ]
    Measurement of quality of live six months after uptitration of the recommended medication.


Enrollment: 683
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Training of the GP's, intervention
General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard.
Behavioral: GP's treating HF according the dutch guidelines
Active Comparator: Controle
General practitioners giving care as usual to their heart failure patients.
Behavioral: GP's treating HF according the dutch guidelines

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file.

Exclusion Criteria:

  • Incapacitated patients with a life expectancy of less than 2 months
  • Seniles
  • Patients who do not speak the Dutch language
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drs. Mark M J Valk, assistant professor, Julius Center
ClinicalTrials.gov Identifier: NCT01662323     History of Changes
Other Study ID Numbers: TOPHU01
First Submitted: August 2, 2012
First Posted: August 10, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Drs. Mark M J Valk, Julius Center:
Heart failure, general practitioner, medical therapy, quality of live

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases