Multicenter Study of Family Nursing to Treat Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Family Focused Nursing

• Registration Number: NCT01378247
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Focused Nursing	Family Focused Nursing	Family Focused Nursing and treatment as usual

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in European Heart Failure Self-Care Behavior Scale	Baseline, three, six and twelve months 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 Major Depression Inventory diagnostic scale	Baseline, three, six and tvelve months
Time for the emergence of mortality	One year
Time for the emergence of total re-admission and re-admission for heart failure	One year

Trial Locations

Locations (3)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark