Clinical trial NCT01378247: Multicenter Study of Family Nursing to Treat Heart Failure
Official title: Family Focused Nursing for Outpatients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Family Nursing
Health-Related Quality of Life
Heart Failure Clinic
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Vejle Hospital
name: Bispebjerg Hospital
First posted: 2011-06-22
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health Related Quality of Life assessed by ≥6 point in Kansas City Cardiomyopathy Questionnaire summary score
timeFrame: Baseline, three, six and twelve months
Secondary outcomes:
measure: Change in European Heart Failure Self-Care Behavior Scale
timeFrame: Baseline, three, six and twelve months months
measure: Change in Family Functioning, Health and Social Support scale
timeFrame: Baseline, three, six and tvelve months
measure: Change in Self-Efficacy for Managing Chronic Disease 6-item scale
timeFrame: Baseline, three, six and tvelve months
measure: Change in Major Depression Inventory diagnostic scale
timeFrame: Baseline, three, six and tvelve months
measure: Time for the emergence of total re-admission and re-admission for heart failure
timeFrame: One year
measure: Time for the emergence of mortality
timeFrame: One year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: University of Southern Denmark
name: Birte Oestergaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: