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Multicenter Study of Family Nursing to Treat Heart Failure

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Family Focused Nursing

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Bispebjerg Hospital
Odense University Hospital
Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Family Focused Nursing

Arm Description

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

Family Focused Nursing and treatment as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in European Heart Failure Self-Care Behavior Scale

Change in Family Functioning, Health and Social Support scale

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

Change in Major Depression Inventory diagnostic scale

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

Time for the emergence of mortality

Full Information

NCT ID

NCT01378247

First Posted

June 16, 2011

Last Updated

April 14, 2017

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital, Vejle Hospital, Bispebjerg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01378247

Brief Title

Multicenter Study of Family Nursing to Treat Heart Failure

Official Title

Family Focused Nursing for Outpatients With Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital, Vejle Hospital, Bispebjerg Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

468 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment as usual

Arm Type

No Intervention

Arm Description

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

Arm Title

Family Focused Nursing

Arm Type

Experimental

Arm Description

Family Focused Nursing and treatment as usual

Intervention Type

Behavioral

Intervention Name(s)

Family Focused Nursing

Other Intervention Name(s)

Family, Nursing, Heart Failure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Health Related Quality of Life assessed by ≥6 point in Kansas City Cardiomyopathy Questionnaire summary score

Description

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

Time Frame

Baseline, three, six and twelve months

Secondary Outcome Measure Information:

Title

Change in European Heart Failure Self-Care Behavior Scale

Time Frame

Baseline, three, six and twelve months months

Title

Change in Family Functioning, Health and Social Support scale

Time Frame

Baseline, three, six and tvelve months

Title

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

Time Frame

Baseline, three, six and tvelve months

Title

Change in Major Depression Inventory diagnostic scale

Time Frame

Baseline, three, six and tvelve months

Title

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

Time Frame

One year

Title

Time for the emergence of mortality

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Birte Oestergaard, PhD

Organizational Affiliation

University of Southern Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Vejle Hospital

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

Multicenter Study of Family Nursing to Treat Heart Failure

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