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

November 13, 2012 updated by: Drs. Mark M J Valk, Julius Center

Therapy OPtimization Heart Failure Utrecht

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: up to 1 year
Measurement of quality of live six months after uptitration of the recommended medication.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julius Center

Collaborators

Agis Zorgverzekeringen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPHU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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