Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Werner Herzog
ORCID ID
Contact details
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
+49 (0)6221 56 8649
Wolfgang_Herzog@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TTT
Study hypothesis
The intervention will result in a change of the quality of life (Qol) (SF-36, scale physical function) of at least 7% compared to control.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Congestive Heart Failure (CHF)
Intervention
For the control group, a classic state of the art lecture of 1.5-3 hours on heart failure from a cardiologist is used. For the intervention group, an interactive training of 1.5 days plus a refresher course of 1.5-3 hours plus two quality circles (1.5 hours) is planned. Elements of the training apply to the domains of knowledge (guideline), communication (standardized patients), detection and management of psychiatric co-morbidity and organisation of the practice. An interactive format relating to andragogy is chosen. A tool box will be provided consisting of a variety of management algorithms and other helpful tools.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Primary outcome is health related quality of life (Qol) of patients with heart failure measured with SF-36, scale 1 (physical functioning). Change of Qol is measured from T1 to T2.
Secondary outcome measures
Secondary outcomes are the other dimensions: Qol of SF-36, the disease specific Qol (KCCQ), patient perceived quality of care (EUROPEP), readmission to hospital or death due to heart failure (combined), improvement of heart failure according to BNP.
Overall trial start date
12/10/2005
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Objective left- or bi-ventricular heart failure with an ejection fraction of 40% or less (affirmation of the limitation of the heart with echocardiography, no older then six months)
2. Age ≥40 years
3. Stability of the disease at the point of time of inclusion
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
470 patients, 60 practices with 8 patients per practice
Participant exclusion criteria
1. Primary valvular heart disease with relevant hemodynamic effects
2. Hypertrophic obstructive/restrictive cardiomyopathy (HOCM/RCM)
3. Organ transplantation
4. Acute left ventricular failure
5. Short life expectancy due to a serious concomitant illness
6. Impaired mental state that prevents accurate answers to questions
7. Addictive disorders with continuing drug abuse despite social, legal or professional conflicts
Recruitment start date
12/10/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])
Sponsor details
Hannoversche Straße 28-30
Berlin
10115
Germany
+49 (0)1888 570
Gesundheitsforschung@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19678944
Publication citations
-
Results
Peters-Klimm F, Campbell S, Müller-Tasch T, Schellberg D, Gelbrich G, Herzog W, Szecsenyi J, Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial., Trials, 2009, 10, 68, doi: 10.1186/1745-6215-10-68.