Heidelbergian Integrated Case Management for Chronic Heart Failure in general practice
| ISRCTN | ISRCTN30822978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30822978 |
| Secondary identifying numbers | 01GI0205/21 |
- Submission date
- 23/11/2006
- Registration date
- 28/11/2006
- Last edited
- 11/06/2010
- 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 Wolfgang Herzog
Scientific
Scientific
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HICMan-CHF |
| Study objectives | A randomised controlled trial will be performed to prove the effectiveness of Heidelbergian Integrated Case Management (HICMan). The case management intervention group shows a significantly better outcome with respect to Quality of life (Qol) compared to the control group, at the one year follow-up (t0 to t1). |
| Ethics approval(s) | Ethical consent was approved by the local committee of the University of Heidelberg on the 11th October 2006 (ref: 303/2006) and the committee of the State Chamber of Phycicians of Baden-Württemberg on the 31st October 2006 (ref: B-244-06-f). |
| Health condition(s) or problem(s) studied | Chronic Heart Failure |
| Intervention | Introduction: After enrolment the Case Manager (CM) will need approximately 30 minutes for an introduction of her function and to establish a relationship. Patients will get information about their diseases, realisation of symptoms and self-monitoring. Monitoring by telephone: The CM carries out a telephone monitoring: 1. Low to medium risk (NYHA I/II) - every six weeks, three personal home visits during the year substituting for the telephone monitoring. 2. High risk (NYHA III/IV) - every three weeks, three personal home visits during the year substituting for the telephone monitoring. Home visits: Each home visit (three over the year) will evaluate the following in a structured, but varied way: 1. Physical, cardiac status 2. Self-management 3. Compliance/adherence 4. Depression and anxiety screening 5. Small geriatric assessment 6. Medication management Patient education: 1. Physical activity 2. Smoking 3. Self management Recall-Reminder-Systems: If necessary, active surveillance concerning prescription and doctor follow-up will be applied. Participating doctors will get feedback about their guideline adherence for patients receiving the intervention (data from t0). |
| Intervention type | Other |
| Primary outcome measure | 1. Health related quality of life (Short Form health survey (SF-36), scale physical function. 2. Change of Qol measured from t0 to t1). |
| Secondary outcome measures | 1. Other dimensions of Qol (SF-36) 2. The disease specific Qol (Kansas City Cardiomyopathy Questionnaire [KCCQ]) 3. Patient perceived quality of care (Patient Assessment of Chronic Illness Care [PACIC]) 4. Readmission to hospital or death due to heart failure (combined) 5. Improvement of heart failure according to N-Terminal prohormone Brain Natriuretic Peptide (NT-proBNP) 6. Cost-effectiveness |
| Overall study start date | 01/12/2006 |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Dyspnea New York Heart Association (NYHA) grade I, if hospitalisation due to heart failure within the previous 24 months, or Dyspnea NYHA grade II to IV 2. Objective Congestive Heart Failure (CHF) (left- or bi-ventriucular) ejection fraction of 45% or less (affirmation with echocardiography, no older then 24 months) 3. Age more than or equal to 40 years 4. 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 CardioMyopathy/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 | 01/12/2006 |
| Date of final enrolment | 31/01/2008 |
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]) (Germany)
Not defined
Not defined
Hannoversche Strasse 28-30
Berlin
10115
Germany
| Website | http://www.bmbf.de/en/index.php |
|---|---|
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (ref: 01GI0205/21) (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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/08/2007 | Yes | No | |
| Results article | results | 17/05/2010 | Yes | No |
