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DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark (DenHeart)

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ClinicalTrials.gov Identifier: NCT01926145
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : June 10, 2015
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Aalborg University Hospital
Aarhus University Hospital
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief Summary:

The objective of this study is to describe: 1) Differences in perceived health at hospital discharge between diagnostic groups and in-hospital predicting factors. 2) Perceived health at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) The association between perceived health, sick leave and health care utilization.

The five heart centres in Denmark diagnose and treat about 50.000 patients with different diagnoses every year and offer both invasive and non-invasive treatment.

Perceived health status is measured by self-reported health, quality of life, anxiety and depression and symptoms. Knowledge about perceived health status can help to guide inpatient practise and outpatient follow-up. Furthermore, it can be used to evaluate differences between diagnostic groups, regional differences and predicting factors for perceived health status at hospital discharge and long term morbidity and mortality. Also economic analysis of healthcare utilisation and work ability status are possible.

Five Danish heart centres (Rigshospitalet, Gentofte Hospital, Odense University Hospital, Aarhus University Hospital and Aalborg University Hospital) are all including patients from April 2013 to April 2014. All patients discharged or transferred from one of the heart centres are potential participants in the study. Patients are unselected and consecutively included at hospital discharge. Included patients will be asked to complete and return a questionnaire before they leave the hospital.

The following questionnaires will be used to measure the perceived health status of the patients at hospital discharge: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief Illness Perception Questionnaire, HeartQoL and Edmonton Symptom Assessment Scale. Furthermore 14 ancillary about health and health behaviour are included in the questionnaire. This amounts to a total of 62 items in the questionnaire.

The DenHeart study data collection, database development and reporting of primary outcomes are funded by the five participating heart centres in Denmark. Further funding for registry data, analyses and reporting will be applied for in external funds.


Condition or disease
All Conditions Treated at the Heart Centres

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Study Type : Observational
Actual Enrollment : 16712 participants
Time Perspective: Prospective
Official Title: DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Self-reported health measured by SF-12 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
  2. EQ-5D [ Time Frame: Baseline ]
  3. Brief Illness Perception Questionnaire [ Time Frame: Baseline ]
  4. HeartQoL [ Time Frame: Baseline ]
  5. Edmonton Symptom Assessment Scale [ Time Frame: Baseline ]

Other Outcome Measures:
  1. Morbidity and mortality after 1 and 3 years [ Time Frame: 1 and 3 years after baseline ]
  2. Sick leave and health care utilization [ Time Frame: 1 and 3 years after baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients discharged or transferred from one of the heart centres are potential participants in the study. The diagnostic groups include ischemic heart disease, heart failure, arrhythmia, heart valve disease, endocarditis, congenital heart disease and heart transplantation.
Criteria

Inclusion Criteria:

  • Hospitalized at one of the five heart centres
  • Able to fill out the questionnaire

Exclusion Criteria:

  • <18 years
  • No Danish CPR number
  • For ethical reasons unconscious patients are also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926145


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Gentofte Hospital
Copenhagen, Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Aalborg University Hospital
Aarhus University Hospital
Investigators
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Principal Investigator: Selina K Berg, Ph.D. Rigshospitalet, Denmark

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Selina Kikkenborg Berg, Ph.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01926145     History of Changes
Other Study ID Numbers: DenHeart
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015