Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003159

Trial Description

start of 1:1-Block title

Title

Effect of an education and counselling programme on self-care and care dependency in patients with heart failure

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

EDUC-HF

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patient suffering from heart failure are frequently admitted to an hospital due exacerbation of the disease. One reason for exacerbation is a reduced self-care, i.e. a reduced adherence towards treatment recommendations and a reduced ability to detect symptoms of exacerbation at an early stage and response to it adequately. Self-care can be improved by education and counseling. This study aims to find out if a nurse-led education and counseling session is able to improve patients self-care, care dependency and quality of life. Patient with chronic heart failure admitted to an hospital will receive an individual education and counseling about heart failure with consecutive telephone follow-up over three months (4 calls). During these calls patients will be asked about their self-care behaviors and state of health. After three months patients received heart failure education and counseling will be compared to a similar group of heart failure patients without specific education/counseling. It is assumed that patients with heart failure education/counseling shows improved self-care, care dependency and quality of life

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Heart Failure (HF) is one of the most prevalent diseases in western industrialized countries with high economic and individual burden. Patients with HF suffer from reduced physical and social role functioning and quality of life. Treatment expenses of HF add up to 2% of the total health care expenditure with hospitalisation as the most cost-intensive part of it. Using a nurse-led education and counselling programme to promote self-care in patients with HF is a promising strategy to maintain or enhance health and quality of life of the patient as well as to prevent exacerbation of HF with consecutive need of health care services. To date there is no evidence that such a strategy is working for a German HF population. Therefore the aim of the study is to determine the effect of a nurse-led education and counselling programme on self-care, care dependency and quality of life in a German HF population.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003159
  •   2011/07/25
  •   [---]*
  •   yes
  •   Approved
  •   107/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I50 -  Heart failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group:
    Patient will receive an education/counselling session during hospitalisation or their attendance at the outpatient heart failure clinic. After discharge a telephone follow-up will be initiated over a period of three months.
    Intervention will be performed by a master-degree prepared nurse (nursing science) with extensive experience in caring for patients with heart failure.
    During the education/counselling session information about following topics will be provided: (1) the physiology of the circulation system, (2) the pathophysiology of heart failure with a special focus on fluid retention and its impact, (3) possible signs and symptoms of worsening heart failure, (4) medication, (5) measures to recognize worsening heart failure early on (daily control of weight, blood pressure, heart beat, oedema, signs/symptom of HF), (6) travelling with HF, (7) lifestyle changes (exercise, food, fluid restriction, smoking cessation, exercise) and (8) other issues which were coming up during the session.
    In addition the patient will receive a patient booklet about HF published by the German Competence Network Heart Failure (CNHF) and a diary in which he is advised to document body weight, blood pressure, heart rate, oedema on a daily basis and if necessary any kind of noticeable problems which could be related to HF.
    If desired the patient will receive information about a cardiac support group located near the hospital, a sport group for patient with cardiac diseases near the domicile of the patient and the URL of the web side for heart failure patients of the European Society of Cardiology (www.heartfailurematters.org).
    After discharge from hospital the patient will receive four telephone calls within three months (1, 4, 8 and 12 weeks after discharge). During these telephone calls the patient will be asked about body weight, blood pressure, heart beat, oedema, fluid restriction, any signs of worsening heart failure, changes in medical treatment and rehospitalisation. In case of any signs of needs for improvement regarding self-care behaviours the education content of the specific topic will be repeated.
  •   Controll group: Care as usual
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Other
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Self-care measured with the German version of the 9-item European Heart Failure Self-care Behaviour Scale (at time of enrolment and after three months).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Care dependency measured with the Care dependency scale
Quality of life measured with the Kansas City Cardiomyopathie Questionnaire (at time of enrolment and after three months).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/04/05
  •   128
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Chronic systolic heart failure with
LVEF <=40
NYHA II-IV

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

First time heart failure; hospitalisation within 14 days prior enrolment;disorientation towards time/place/person/situation; dementia; not able to sufficiently read/understand German; discharge to another department/hospital/reghabilitation center; life expectancy < 3 months according to attending physician; ICD/CRT implantation within 3 months prior enrolment; heart surgery (Valve surgery, CABG) within 3 months prior enrolment; age under 18 years; no telefon connection; decline to participate; participation in a study with similar aim

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg-Bad KrozingenPflegedirektion
    • Mr.  Dipl. Pflegepäd. (FH), MSc Pflegewissenschaft  Stefan  Köberich 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitäts-Herzzentrum Freiburg-Bad KrozingenPflegedirektion
    • Mr.  Dipl. Pflegepäd. (FH), MSc Pflegewissenschaft  Stefan  Köberich 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitäts-Herzzentrum Freiburg-Bad KrozingenPflegedirektion
    • Mr.  Dipl. Pflegepäd. (FH), MSc Pflegewissenschaft  Stefan  Köberich 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitäts-Herzzentrum Freiburg-Bad KrozingenPflegedirektion
    • Mr.  Dipl. Pflegepäd. (FH), MSc Pflegewissenschaft  Stefan  Köberich 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/01/02
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Köberich, S.; Lohrmann, C.; Mittag, O.; Dassen, T. (2015): Effect of a hospital-based education programme on self-care behavior, care dependency and quality of life in patients with heart failure – a randomized controlled trial. J Clin Nurs doi: 10.1111/jocn.12766
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.