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
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
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
NCT ID
NCT01662323
First Posted
August 2, 2012
Last Updated
November 13, 2012
Sponsor
Julius Center
Collaborators
Agis Zorgverzekeringen
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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