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Completed

NCT Number: NCT01378247

Multicenter Study of Family Nursing to Treat 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Focused Nursing

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.

Other names: Family, Nursing, Heart Failure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in European Heart Failure Self-Care Behavior Scale

    Time frame: Baseline, three, six and twelve months months

  2. Change in Family Functioning, Health and Social Support scale

    Time frame: Baseline, three, six and tvelve months

  3. Change in Self-Efficacy for Managing Chronic Disease 6-item scale

    Time frame: Baseline, three, six and tvelve months

  4. Change in Major Depression Inventory diagnostic scale

    Time frame: Baseline, three, six and tvelve months

  5. Time for the emergence of total re-admission and re-admission for heart failure

    Time frame: One year

  6. Time for the emergence of mortality

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • Odense University Hospital
  • Vejle Hospital

Registry information

Official study title

Family Focused Nursing for Outpatients With Heart Failure

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2011
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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