Train the trainer
| ISRCTN | ISRCTN08601529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08601529 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/09/2005
- Registration date
- 14/12/2005
- Last edited
- 20/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Werner Herzog
Scientific
Scientific
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 8649 |
|---|---|
| Wolfgang_Herzog@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | TTT |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 12/10/2005 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 470 patients, 60 practices with 8 patients per practice |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/10/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
69120
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])
Government
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
| Phone | +49 (0)1888 570 |
|---|---|
| Gesundheitsforschung@dlr.de | |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/08/2009 | Yes | No |
