Multicenter Study of Family Nursing to Treat Heart Failure

April 14, 2017 updated by: Birte Oestergaard, University of Southern Denmark

Family Focused Nursing for Outpatients With Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

468

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family Focused Nursing
Family Focused Nursing and treatment as usual
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.
Other Names:
  • Family
  • Nursing
  • Heart Failure
No Intervention: Treatment as usual
Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in heart failure.

What is the study measuring?

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
Time Frame: 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
Baseline, three, six and twelve months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in European Heart Failure Self-Care Behavior Scale
Time Frame: Baseline, three, six and twelve months months
Baseline, three, six and twelve months months
Change in Family Functioning, Health and Social Support scale
Time Frame: Baseline, three, six and tvelve months
Baseline, three, six and tvelve months
Change in Self-Efficacy for Managing Chronic Disease 6-item scale
Time Frame: Baseline, three, six and tvelve months
Baseline, three, six and tvelve months
Change in Major Depression Inventory diagnostic scale
Time Frame: Baseline, three, six and tvelve months
Baseline, three, six and tvelve months
Time for the emergence of total re-admission and re-admission for heart failure
Time Frame: One year
One year
Time for the emergence of mortality
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Bispebjerg Hospital
Vejle Hospital

Investigators

  • Principal Investigator: Birte Oestergaard, PhD, University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNR-20110068-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be entered into Odense Patient data Explorative Network (OPEN) database

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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