Plain English Summary
Not provided at time of registration
Trial website
http://www.klinikum.uni-heidelberg.de/HICMAN-gestartet-7-2006.102718.0.html
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01GI0205/21
Study information
Scientific title
Acronym
HICMan-CHF
Study hypothesis
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
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).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/12/2006
Overall trial end date
31/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/12/2006
Recruitment end date
31/01/2008
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]) (Germany)
Sponsor details
Hannoversche Strasse 28-30
Berlin
10115
Germany
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (ref: 01GI0205/21) (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
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17716364
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20478035
Publication citations
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Results
Peters-Klimm F, Campbell S, Hermann K, Kunz CU, Müller-Tasch T, Szecsenyi J, , Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial., Trials, 2010, 11, 56, doi: 10.1186/1745-6215-11-56.
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Peters-Klimm F, Müller-Tasch T, Schellberg D, Gensichen J, Muth C, Herzog W, Szecsenyi J, Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management)., BMC Cardiovasc Disord, 2007, 7, 25, doi: 10.1186/1471-2261-7-25.