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.
|
|
|
Active Comparator: Controle
General practitioners giving care as usual to their heart failure patients.
|
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
Collaborators
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
- 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.
- 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.
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
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.