Multicenter Study of Family Nursing to Treat Heart Failure

Heart Failure Clinical Trial

Official title:

Family Focused Nursing for Outpatients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378247
• Other study ID #: UNR-20110068-3
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: April 14, 2017
• Start date: June 2011
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Family 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Odense University Hospital	Odense
Denmark	Vejle Hospital	Vejle

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Bispebjerg Hospital, Odense University Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health Related Quality of Life assessed by =6 point in Kansas City Cardiomyopathy Questionnaire summary score	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	Baseline, three, six and twelve months
Secondary	Change in European Heart Failure Self-Care Behavior Scale		Baseline, three, six and twelve months months
Secondary	Change in Family Functioning, Health and Social Support scale		Baseline, three, six and tvelve months
Secondary	Change in Self-Efficacy for Managing Chronic Disease 6-item scale		Baseline, three, six and tvelve months
Secondary	Change in Major Depression Inventory diagnostic scale		Baseline, three, six and tvelve months
Secondary	Time for the emergence of total re-admission and re-admission for heart failure		One year
Secondary	Time for the emergence of mortality		One year