Condition category
Circulatory System
Date applied
07/09/2005
Date assigned
14/12/2005
Last edited
20/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.klinikum.uni-heidelberg.de/index.php?id=5528

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 measures

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

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19678944

Publication citations

  1. 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.

Additional files

Editorial Notes