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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
GP's treating HF according the dutch guidelines
Sponsored by
Julius Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, general practitioner, medical therapy, quality of live

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Training of the GP's, intervention

    Controle

    Arm Description

    General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard.

    General practitioners giving care as usual to their heart failure patients.

    Outcomes

    Primary Outcome Measures

    proportion recommended medication for patients with heart failure
    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
    Measurement of quality of live six months after uptitration of the recommended medication.

    Full Information

    First Posted
    August 2, 2012
    Last Updated
    November 13, 2012
    Sponsor
    Julius Center
    Collaborators
    Agis Zorgverzekeringen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01662323
    Brief Title
    Study to Improve the Treatment of Patients With Heart Failure by General Practitioners
    Acronym
    TOPHU
    Official Title
    Therapy OPtimization Heart Failure Utrecht
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Julius Center
    Collaborators
    Agis Zorgverzekeringen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Heart failure, general practitioner, medical therapy, quality of live

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    683 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Training of the GP's, intervention
    Arm Type
    Active Comparator
    Arm Description
    General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard.
    Arm Title
    Controle
    Arm Type
    Active Comparator
    Arm Description
    General practitioners giving care as usual to their heart failure patients.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GP's treating HF according the dutch guidelines
    Primary Outcome Measure Information:
    Title
    proportion recommended medication for patients with heart failure
    Description
    the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    QoL
    Description
    Measurement of quality of live six months after uptitration of the recommended medication.
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26446696
    Citation
    Valk MJ, Hoes AW, Mosterd A, Landman MA, Broekhuizen BD, Rutten FH. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial. BMC Fam Pract. 2015 Oct 7;16:130. doi: 10.1186/s12875-015-0347-1.
    Results Reference
    derived
    PubMed Identifier
    26170650
    Citation
    Valk MJ, Broekhuizen BD, Mosterd A, Zuithoff NP, Hoes AW, Rutten FH. COPD in patients with stable heart failure in the primary care setting. Int J Chron Obstruct Pulmon Dis. 2015 Jun 26;10:1219-24. doi: 10.2147/COPD.S77085. eCollection 2015.
    Results Reference
    derived

    Learn more about this trial

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

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