|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01378247 |
|
Date of registration:
|
16/06/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Multicenter Study of Family Nursing to Treat Heart Failure
|
|
Scientific title:
|
Family Focused Nursing for Outpatients With Heart Failure |
|
Date of first enrolment:
|
June 2011 |
|
Target sample size:
|
468 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01378247 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Birte Oestergaard, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Southern Denmark |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure
|
|
Intervention(s)
|
|
Behavioral: Family Focused Nursing
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
Change in Self-Efficacy for Managing Chronic Disease 6-item scale
[Time Frame: Baseline, three, six and tvelve months]
|
|
Change in Family Functioning, Health and Social Support scale
[Time Frame: Baseline, three, six and tvelve months]
|
|
Change in European Heart Failure Self-Care Behavior Scale
[Time Frame: Baseline, three, six and twelve months months]
|
|
Change in Major Depression Inventory diagnostic scale
[Time Frame: Baseline, three, six and tvelve months]
|
|
Time for the emergence of mortality
[Time Frame: One year]
|
|
Time for the emergence of total re-admission and re-admission for heart failure
[Time Frame: One year]
|
|
Secondary ID(s)
|
|
UNR-20110068-3
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|