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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

  1. Self-reported health measured by SF-12

    Measured: Baseline

Secondary outcomes (5)

  1. Hospital Anxiety and Depression Scale

    Measured: Baseline

  2. EQ-5D

    Measured: Baseline

  3. Brief Illness Perception Questionnaire

    Measured: Baseline

  4. HeartQoL

    Measured: Baseline

  5. 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.

  1. First posted20 Aug 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

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)
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 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

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.

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