NCT01378247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

5.6 years

First QC Date

June 16, 2011

Last Update Submit

April 14, 2017

Conditions

Heart Failure

Keywords

Heart FailureFamily NursingHealth-Related Quality of LifeHeart Failure Clinic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Treatment as usual

NO INTERVENTION

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

Family Focused Nursing

EXPERIMENTAL

Family Focused Nursing and treatment as usual

Behavioral: Family Focused Nursing

Interventions

Family Focused NursingBEHAVIORAL

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.

Also known as: Family, Nursing, Heart Failure
Family Focused Nursing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Nursing

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Birte Oestergaard, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 22, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

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

Locations

DK(3)