Heart FailureNCT01378247
Multicenter Study of Family Nursing to Treat Heart Failure
A study testing Family Focused Nursing in people with Heart Failure, run by University of Southern Denmark at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Family Focused Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesDenmark
- Study dates
- Jun 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Bispebjerg Hospital
Copenhagen, 2400
Odense University Hospital
Odense, 5000
Vejle Hospital
Vejle, 7100
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Family Focused Nursing
- Keywords
- Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused NursingBehavioural
Also called Family, Nursing, Heart Failure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Family Focused Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, three, six and twelve months
Secondary outcomes (6)
Change in European Heart Failure Self-Care Behavior Scale
Measured: Baseline, three, six and twelve months months
Change in Family Functioning, Health and Social Support scale
Measured: Baseline, three, six and tvelve months
Change in Self-Efficacy for Managing Chronic Disease 6-item scale
Measured: Baseline, three, six and tvelve months
Change in Major Depression Inventory diagnostic scale
Measured: Baseline, three, six and tvelve months
Time for the emergence of total re-admission and re-admission for heart failure
Measured: One year
Time for the emergence of mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Vejle Hospital, Bispebjerg Hospital
- Responsible party
- Principal investigator, Birte Oestergaard, University of Southern Denmark
- Investigators
- Birte Oestergaard, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378247
- Sponsor's protocol ID
- UNR-20110068-3
- Status last verified
- Apr 2017
- First submitted
- 16 Jun 2011
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be entered into Odense Patient data Explorative Network (OPEN) database
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Focused Nursing for Outpatients With Heart Failure
- ClinicalTrials.gov ID
- NCT01378247
- Acronym / sponsor ID
- UNR-20110068-3
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Family Nursing, Health-Related Quality of Life, Heart Failure Clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Vejle Hospital, Bispebjerg Hospital
- Study start
- Jun 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Family Focused NursingFamily Focused Nursing and treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Focused NursingAlso: Family, Nursing, Heart FailureAll 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. | Behavioural | Family Focused Nursing |
Primary outcome
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
6 secondary outcomes
Change in European Heart Failure Self-Care Behavior Scale
Time frame: Baseline, three, six and twelve months months
Change in Family Functioning, Health and Social Support scale
Time frame: 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
Change in Major Depression Inventory diagnostic scale
Time frame: Baseline, three, six and tvelve months
Time for the emergence of total re-admission and re-admission for heart failure
Time frame: One year
Time for the emergence of mortality
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: Yes. Data will be entered into Odense Patient data Explorative Network (OPEN) database
Related trials for Heart Failure
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Active, not recruiting
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Oestergaard, PhD principal investigator
University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Nursing in people with Heart Failure, run by University of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.