Multicenter Study of Family Nursing to Treat Heart Failure

Study Overview
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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.

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.

Official Title
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Family Focused Nursing for Outpatients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Family Focused Nursing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in heart failure. | |
| Experimental: Family Focused Nursing<br>Family Focused Nursing and treatment as usual | Behavioral: Family Focused Nursing<br>* 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.<br>* Other names: Heart Failure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 total re-admission and re-admission for heart failure |  | One year | 
| Time for the emergence of mortality |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic