Multicenter Study of Family Nursing to Treat Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Family Focused Nursing

Family Focused Nursing and treatment as usual

Group Type EXPERIMENTAL

Family Focused Nursing

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Family Nursing Heart Failure

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes