All Conditions Treated at the Heart Centres Clinical Trial
— DenHeartOfficial title:
DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark
| Verified date | June 2015 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Dataprotection Agency |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 16712 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | Aalborg Universitetshospital, Aarhus University Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Morbidity and mortality after 1 and 3 years | 1 and 3 years after baseline | No | |
| Other | Sick leave and health care utilization | 1 and 3 years after baseline | No | |
| Primary | Self-reported health measured by SF-12 | Baseline | No | |
| Secondary | Hospital Anxiety and Depression Scale | Baseline | No | |
| Secondary | EQ-5D | Baseline | No | |
| Secondary | Brief Illness Perception Questionnaire | Baseline | No | |
| Secondary | HeartQoL | Baseline | No | |
| Secondary | Edmonton Symptom Assessment Scale | Baseline | No |