Condition category
Circulatory System
Date applied
23/11/2006
Date assigned
28/11/2006
Last edited
11/06/2010
Prospective/Retrospective
Prospectively 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/HICMAN-gestartet-7-2006.102718.0.html

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Herzog

ORCID ID

Contact details

Im Neuenheimer Feld 410
Heidelberg
69120
Germany

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 measures

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

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

http://www.bmbf.de/en/index.php

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes