Feasibility and practical utility of the revised 9-Item European Heart Failure Self-care Behaviour Scale (EHFScB-9) in the German speaking part of Switzerland: a feasibility study

ISRCTN	ISRCTN36234836
DOI	https://doi.org/10.1186/ISRCTN36234836
Secondary identifying numbers	N/A

Submission date: 14/09/2011
Registration date: 06/10/2011
Last edited: 10/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Heart failure is one of the most common chronic diseases in Switzerland and represents a major burden to society and for the patient. It is caused by the heart failing to pump enough blood around the body at the right pressure. In dealing with the disease and the symptoms, patients should practice adequate self-care and follow treatment recommendations through behavioral changes. Several studies have shown that improved self-care leads to a better quality of life for patients. The revised European Heart Failure Self-care Behavior Scale (EHFScB-9) is a scientifically proved frequently used questionnaire to assess the self-care behavior of heart failure patients. The questionnaire consists of nine items, which the patient completes on a scale from 1 (I completely agree) to 5 (I strongly disagree with). The individual items can identify in which areas the patient still has need for education. The German-language version of EHFScB-9 is already used in practice, but currently there are no studies testing its practicability in the context of Swiss-German heart failure patients. This study aims to test the practicability and clinical utility of the German version of EHFScB-9 in a health institution in Switzerland.

Who can participate?
In- and out-patients aged 18 or over at the participating hospital with a diagnosis of heart failure, and for inpatients nurses responsible for the participating patient can take part in this study.

What does the study involve?
Participants are invited to complete the German version of the questionnaire and have to think aloud while filling in the answers. After that follows a short interview with the sub-investigator with questions about the questionnaire. Staff nurses also have to complete the questionnaire from the perspective of the assigned patient and are asked about the benefit and clinical utility of the questionnaire.

What are the possible benefits and risks of participating?
No adverse effects or risks for are expected.

Where is the study run from?
The study takes place in the outpatient clinic and two inpatients wards of a cardiology department in the North-East of Switzerland.

When is the study starting and how long is it expected to run for?
September 2011 to March 2012

Who is funding the study?
Kantonsspital St. Gallen (Switzerland)

Who is the main contact?
1. Verena Cattilaz-Langenauer (vreni.cattilaz@kssg.ch)
2. Dr Virpi Hantikainen (virpi.hantikainen@fhsg.ch)

Contact information

Mrs Verena Cattilaz
Scientific

Entwicklung Pflege am Kantonsspital St. Gallen
Spital Rorschach
Heidenerstrasse 11
Rorschach
9400
Switzerland

Phone	+41 (0)71 858 34 41
Email	vreni.cattilaz@kssg.ch

Study information

Study design	Descriptive cross-sectional concurrent mixed-methods single-centre study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Feasibility and practicability of the revised 9-Item European Heart Failure Self-Care Behaviour Scale (EHFScB-9) in the German-speaking Switzerland from the perspective of out- and inpatients and their caring nurses: a cross-sectional concurred mixed-methods feasibility study
Study objectives	Is the instrument EHFScB-9 practicable from the perspectives of heart failure patients and their nurses in a Swiss-German population? 1. How do patients score their self-care behavior with the EHFScB-9? 2. How understandable, relevant and ethical are the items of the EHFScB-9 from the perspective of patients? 3. What is the relationship between the EHFScB-9 score and the practicability (comprehensibility and feasibility) of inpatient versus outpatient setting? 4. How do nurses evaluate the practical applicability and the benefits of the EHFScB-9? 5. What is the relationship between the patient self-rated self-care behavior and the nurse ralted self-care behavior based on the EHFScB-9?
Ethics approval(s)	Canton of St. Gallen, Ethics Review Board, 22/08/2011, ref: EKSG 11/080/1b
Health condition(s) or problem(s) studied	Diagnosed heart failure patients
Intervention	A concurrent mixed-methods study will be conducted using first a quantitative descriptive part with data collection of heart failure self-care behaviour and secondly a directly subsequent administrated interview. 1. Outpatients and inpatients and their nurses complete the EHFScB-9 independently and are invited after that to commentate the completing process (cognitive debriefing). 2. After that, patients and nurses will be interviewed for the practicability and usefulness of the EHFScB-9. The estimated duration of study is 20 minutes (complete the questionnaire and interview). There is a single data collection.
Intervention type	Other
Primary outcome measure	1. Practicability of EHFScB-9 2. Patient`s perspective: understandability, relevancy, ethically approved 3. Nurse`s perspective: utility, benefit and incremental effectiveness
Secondary outcome measures	Patient: 1. Socio-demographic data: age, sex, social support, education 2. Disease related data: disease duration, disease severity, comorbidity, obtained heart failure education 3. Health related self-care behavior: EHFScB-9 Nursing staff: 1. Socio-demographic data: age, sex 2. Job-related data: education, degree of employment, years of work experience 3. Estimated patient`s self-care behaviour: EHFScB-9
Overall study start date	01/09/2011
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Setting: one hospital, departement of cardiology, 3 units
Key inclusion criteria	Patients: 1. Diagnosed heart failure New York Heart Association classification (NYHA II-IV) 2. 18 years old 3. Completed informed consent Nursing staff: 1. Nurse responsible for the care of the included patient 2. Works in the department of cardiology 3. Completed informed consent
Key exclusion criteria	Patients: 1. Is not capable to speak or understand German 2. Palliative situation 3. Is not capable to complete a scale because of cognitive impairment
Date of first enrolment	01/09/2011
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

Switzerland

Study participating centre

Entwicklung Pflege am Kantonsspital St. Gallen

Rorschach
9400
Switzerland

Sponsor information

Kantonsspital St. Gallen (Switzerland)
Hospital/treatment centre

c/o Prof Hans Rickli
Departement Kardiologie
Rorschacherstrasse 95
St. Gallen
9007
Switzerland

Website	http://www.kssg.ch/
"ROR"	https://ror.org/00gpmb873

Funders

Funder type

Hospital/treatment centre

Kantonsspital St. Gallen (Switzerland)

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

Editorial Notes

10/02/2016: Publication reference added