Heart Failure
Conditions
Keywords
Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic
Brief summary
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of heart failure outpatients with respect to health-related quality of life.
Detailed description
Quality of life is impaired among patients with heart failure and their next of kin compared to other patients with chronic diseases. Besides, there are still a number of patients who misunderstand or have difficulties remembering the counseling they are provided during the course of illness. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to improvement in quality of life, enhanced illness-management and delayed readmission and mortality among patients with heart failure. However, up till today, only two observational studies have investigated the effect of family intervention on outcomes of treatment for heart failure.
Interventions
BEHAVIORALFamily Focused Nursing
All patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as outpatient sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of six months.
Sponsors
Odense University Hospital
Vejle Hospital
Bispebjerg Hospital
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Referred to follow-up nursing treatment in nurse-led heart failure clinic * Diagnosed chronic heart failure, based on systolic dysfunction (left ventricular ejection fraction (LVEF) ≤40%) * New York Heart Association (NYHA) classification II-IV symptoms * Signed informed consent
Exclusion criteria
* Patients not understanding or talking danish * In terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months * Patients not giving informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Related Quality of Life assessed by ≥6 point in Kansas City Cardiomyopathy Questionnaire summary score | Baseline, three, six and twelve months | The effect of intervention on primary outcome are investigated as longitudinal data at three, six and twelve month. The data are analysed using mixed models |
Secondary
| Measure | Time frame |
|---|---|
| Time for the emergence of total re-admission and re-admission for heart failure | One year |
| Time for the emergence of mortality | One year |
| Change in Major Depression Inventory diagnostic scale | Baseline, three, six and tvelve months |
| Change in Family Functioning, Health and Social Support scale | Baseline, three, six and tvelve months |
| Change in Self-Efficacy for Managing Chronic Disease 6-item scale | Baseline, three, six and tvelve months |
| Change in European Heart Failure Self-Care Behavior Scale | Baseline, three, six and twelve months months |
Countries
Denmark
Outcome results
None listed