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CompletedNCT01926145DenHeartUpdated Jun 10, 2015

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

An observational study in All Conditions Treated at the Heart Centres, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-10.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
16,712
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • All Conditions Treated at the Heart Centres
03

In context

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 39 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Time perspective
Prospective
Enrollment
16,712 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Self-reported health measured by SF-12

    Time frame: Baseline

Secondary outcomes

  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 outcomes

  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

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Study locations

5 sites
  • 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
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References and documents

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 37027133 ↗
  • Dalsgaard 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 36124692 ↗
  • Mols 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 35543021 ↗
  • Risom 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 35275884 ↗
  • Christensen 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 34224466 ↗
  • Nielsen 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 32857268 ↗
  • Christensen 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 31910859 ↗
  • Berg 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2013
First posted
Aug 20, 2013
Start
Apr 2013
Primary completionActual
Apr 2014
CompletionActual
Apr 2014
Last update
Jun 10, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01926145
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Selina Kikkenborg Berg (Ph.D., Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Aug 20, 2013
Start date
Apr 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jun 10, 2015

Study contacts

Selina K Berg, Ph.D.
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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