All Conditions Treated at the Heart CentresDenHeartNCT01926145
DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark
An observational study of All Conditions Treated at the Heart Centres, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Conditions Treated at the Heart Centres
- How many people
- 16,712 participants
- Where
- 5 sitesDenmark
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hospitalized at one of the five heart centres
- Able to fill out the questionnaire
Who cannot join
- <18 years
- No Danish CPR number
- For ethical reasons unconscious patients are also excluded.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Gentofte Hospital
Copenhagen
Rigshospitalet, Copenhagen University Hospital
Copenhagen
Odense University Hospital
Odense
About this study
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported health measured by SF-12
Measured: Baseline
Secondary outcomes (5)
Hospital Anxiety and Depression Scale
Measured: Baseline
EQ-5D
Measured: Baseline
Brief Illness Perception Questionnaire
Measured: Baseline
HeartQoL
Measured: Baseline
Edmonton Symptom Assessment Scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for All Conditions Treated at the Heart CentresStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 16,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina K Berg, Ph.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926145
- Sponsor's protocol ID
- DenHeart
- Acronym
- DenHeart
- Status last verified
- Jun 2015
- First submitted
- 29 Jul 2013
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wagner MK, Christensen AV, Hassager C, Stenbaek DS, Ekholm O, Borregaard B, Thrysoee L, Rasmussen TB, Thorup CB, Mols RE, Juel K, Berg SK. Sex Differences in Patient-Reported Outcomes in the Immediate Recovery Period After Resuscitation: Findings From the Cross-sectional DenHeart Survey. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):279-287. doi: 10.1097/JCN.0000000000000914. Epub 2022 Apr 27.
PubMed 37027133Dalsgaard JL, Hansen MS, Thrysoee L, Ekholm O, Thorup CB, Mols RE, Rasmussen TB, Christensen AV, Berg SK, Pedersen AK, Jensen LO, Mogensen CB, Borregaard B. Self-reported health and adverse outcomes among women living with symptoms of angina or unspecific chest pain but no diagnosis of obstructive coronary artery disease-findings from the DenHeart study. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):506-515. doi: 10.1093/eurjcn/zvac085.
PubMed 36124692Mols RE, Borregaard B, Logstrup BB, Rasmussen TB, Thrysoee L, Thorup CB, Christensen AV, Ekholm O, Rasmussen AA, Eiskjaer H, Risor BW, Berg SK. Patient-reported outcome is associated with health care costs in patients with ischaemic heart disease and arrhythmia. Eur J Cardiovasc Nurs. 2023 Jan 12;22(1):23-32. doi: 10.1093/eurjcn/zvac030.
PubMed 35543021Risom SS, Thygesen LC, Rasmussen TB, Borregaard B, Norgaard MW, Mols R, Christensen AV, Thorup CB, Thrysoee L, Juel K, Ekholm O, Berg SK. Association Between Risk Factors and Readmission for Patients With Atrial Fibrillation Treated With Catheter Ablation: Results From the Nationwide DenHeart Study. J Cardiovasc Nurs. 2023 Jan-Feb 01;38(1):E31-E39. doi: 10.1097/JCN.0000000000000900. Epub 2022 Mar 10.
PubMed 35275884Christensen AV, Cromhout PF, Jorgensen MB, Ekholm O, Juel K, Svendsen JH, Rasmussen TB, Borregaard B, Mols RE, Thrysoee L, Thorup CB, Berg SK. Cause of Death Among Cardiac Patients With and Without Anxiety. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E122-E128. doi: 10.1097/JCN.0000000000000832.
PubMed 34224466Nielsen SN, Rasmussen TB, Lassen JF, Berg SK, Thrysoee L, Moller JE, Jensen LO, Thuesen AL, Christensen AV, Ekholm O, Mols R, Thorup CB, Borregaard B. The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI). Qual Life Res. 2020 Nov;29(11):3017-3029. doi: 10.1007/s11136-020-02573-8. Epub 2020 Aug 28.
PubMed 32857268Christensen AV, Dixon JK, Juel K, Ekholm O, Rasmussen TB, Borregaard B, Mols RE, Thrysoe L, Thorup CB, Berg SK. Psychometric properties of the Danish Hospital Anxiety and Depression Scale in patients with cardiac disease: results from the DenHeart survey. Health Qual Life Outcomes. 2020 Jan 7;18(1):9. doi: 10.1186/s12955-019-1264-0.
PubMed 31910859Berg SK, Svanholm J, Lauberg A, Borregaard B, Herning M, Mygind A, Christensen AV, Christensen AI, Ekholm O, Juel K, Thrysoe L. Patient-reported outcomes at hospital discharge from Heart Centres, a national cross-sectional survey with a register-based follow-up: the DenHeart study protocol. BMJ Open. 2014 May 2;4(5):e004709. doi: 10.1136/bmjopen-2013-004709.
PubMed 24793253
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark
- ClinicalTrials.gov ID
- NCT01926145
- Acronym / sponsor ID
- DenHeart / DenHeart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,712 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Aug 2013 (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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Hospitalized at one of the five heart centres
- Able to fill out the questionnaire
Key exclusion criteria (3 listed)
- <18 years
- No Danish CPR number
- For ethical reasons unconscious patients are also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported health measured by SF-12
Time frame: Baseline
5 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Baseline
EQ-5D
Time frame: Baseline
Brief Illness Perception Questionnaire
Time frame: Baseline
HeartQoL
Time frame: Baseline
Edmonton Symptom Assessment Scale
Time frame: Baseline
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 10 Jun 2015.
- Derived from this study: PubMed 37027133Wagner MK, Christensen AV, Hassager C, Stenbaek DS, Ekholm O, Borregaard B, Thrysoee L, Rasmussen TB, Thorup CB, Mols RE, Juel K, Berg SK. Sex Differences in Patient-Reported Outcomes in the Immediate Recovery Period After Resuscitation: Findings From the Cross-sectional DenHeart Survey. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):279-287. doi: 10.1097/JCN.0000000000000914. Epub 2022 Apr 27.
- Derived from this study: PubMed 36124692Dalsgaard JL, Hansen MS, Thrysoee L, Ekholm O, Thorup CB, Mols RE, Rasmussen TB, Christensen AV, Berg SK, Pedersen AK, Jensen LO, Mogensen CB, Borregaard B. Self-reported health and adverse outcomes among women living with symptoms of angina or unspecific chest pain but no diagnosis of obstructive coronary artery disease-findings from the DenHeart study. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):506-515. doi: 10.1093/eurjcn/zvac085.
- Derived from this study: PubMed 35543021Mols RE, Borregaard B, Logstrup BB, Rasmussen TB, Thrysoee L, Thorup CB, Christensen AV, Ekholm O, Rasmussen AA, Eiskjaer H, Risor BW, Berg SK. Patient-reported outcome is associated with health care costs in patients with ischaemic heart disease and arrhythmia. Eur J Cardiovasc Nurs. 2023 Jan 12;22(1):23-32. doi: 10.1093/eurjcn/zvac030.
- Derived from this study: PubMed 35275884Risom SS, Thygesen LC, Rasmussen TB, Borregaard B, Norgaard MW, Mols R, Christensen AV, Thorup CB, Thrysoee L, Juel K, Ekholm O, Berg SK. Association Between Risk Factors and Readmission for Patients With Atrial Fibrillation Treated With Catheter Ablation: Results From the Nationwide DenHeart Study. J Cardiovasc Nurs. 2023 Jan-Feb 01;38(1):E31-E39. doi: 10.1097/JCN.0000000000000900. Epub 2022 Mar 10.
- Derived from this study: PubMed 34224466Christensen AV, Cromhout PF, Jorgensen MB, Ekholm O, Juel K, Svendsen JH, Rasmussen TB, Borregaard B, Mols RE, Thrysoee L, Thorup CB, Berg SK. Cause of Death Among Cardiac Patients With and Without Anxiety. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E122-E128. doi: 10.1097/JCN.0000000000000832.
- Derived from this study: PubMed 32857268Nielsen SN, Rasmussen TB, Lassen JF, Berg SK, Thrysoee L, Moller JE, Jensen LO, Thuesen AL, Christensen AV, Ekholm O, Mols R, Thorup CB, Borregaard B. The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI). Qual Life Res. 2020 Nov;29(11):3017-3029. doi: 10.1007/s11136-020-02573-8. Epub 2020 Aug 28.
- Derived from this study: PubMed 31910859Christensen AV, Dixon JK, Juel K, Ekholm O, Rasmussen TB, Borregaard B, Mols RE, Thrysoe L, Thorup CB, Berg SK. Psychometric properties of the Danish Hospital Anxiety and Depression Scale in patients with cardiac disease: results from the DenHeart survey. Health Qual Life Outcomes. 2020 Jan 7;18(1):9. doi: 10.1186/s12955-019-1264-0.
- Derived from this study: PubMed 24793253Berg SK, Svanholm J, Lauberg A, Borregaard B, Herning M, Mygind A, Christensen AV, Christensen AI, Ekholm O, Juel K, Thrysoe L. Patient-reported outcomes at hospital discharge from Heart Centres, a national cross-sectional survey with a register-based follow-up: the DenHeart study protocol. BMJ Open. 2014 May 2;4(5):e004709. doi: 10.1136/bmjopen-2013-004709.
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.
Selina K Berg, Ph.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Conditions Treated at the Heart Centres, run by Copenhagen University Hospital, Rigshospitalet at 5 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 2 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Self-reported health measured by SF-12 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926145, which also lists 8 linked publications.
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 10 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.