Multicenter Study of Family Nursing to Treat Heart Failure

University of Southern Denmark (SDU)

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Family Focused Nursing

Study type: Interventional

Funder types: Other

Identifiers

NCT01378247

UNR-20110068-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in heart failure.

Family Focused Nursing

Experimental group

Description:

Family Focused Nursing and treatment as usual

Treatment:

Behavioral: Family Focused Nursing