Heidelbergian Integrated Case Management for Chronic Heart Failure in general practice

ISRCTN	ISRCTN30822978
DOI	https://doi.org/10.1186/ISRCTN30822978
Protocol serial number	01GI0205/21
Sponsor	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (ref: 01GI0205/21) (Germany)

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

Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Health related quality of life (Short Form health survey (SF-36), scale physical function. 2. Change of Qol measured from t0 to t1).
Key secondary outcome measure(s)	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
Completion date	31/01/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	17/05/2010		Yes	No
Protocol article	protocol	23/08/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes