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Completed

NCT Number: NCT01926145

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Odense University Hospital
  • University Hospital, Gentofte, Copenhagen

Registry information

Acronym: DenHeart

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2013
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.