NCT01662323

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
683

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Jun 2009

Typical duration for phase_4 heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

August 2, 2012

Last Update Submit

November 13, 2012

Conditions

Keywords

Heart failure, general practitioner, medical therapy, quality of live

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 6 months

Secondary Outcomes (1)

  • QoL

    up to 1 year

Study Arms (2)

Training of the GP's, intervention

ACTIVE COMPARATOR

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

Controle

ACTIVE COMPARATOR

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

Behavioral: GP's treating HF according the dutch guidelines

Interventions

ControleTraining of the GP's, intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Incapacitated patients with a life expectancy of less than 2 months
  • Seniles
  • Patients who do not speak the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 10, 2012

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-11