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NCT Number: NCT06967324

GRACE - Graduated Response for Advanced COPD With Enhanced Support

The aim of this study is to explore the feasibility and potential for a positive impact of a graduated response for advanced COPD with Enhanced Support. The study is a randomized controlled trial of:

* systematic needs assessment * advance care planning * crossectoral virtual conferences. Researchers will compare quality of life and healthcare use of the intervention group with a control group that will be assessed for intervention need at the last follow-up.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital - Hvidovre

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Isabella Drachmann, MSc.

CONTACT

[email protected]

+45 24 34 21 35

Kirstine Benthien, Ph.D.

CONTACT

About this study

The current study is a non-blinded randomized controlled pilot trial. The control group will be offered treatment as usual whereas the intervention group will be allocated to the GRACE model of care. In total, 100 patients and their caregivers will be included. The patients are all community dwelling and attached to the Outpatient Respiratory Medicine Clinic at Hvidovre Hospital. The patients will be randomized by block randomization to intervention and control group with a ratio of 1:1. Furthermore, the patients will be stratified according to which municipality they belong to, to ensure we gather feasibility data from two municipalities. The control group will be offered to be assessed for their eligibility for palliative care through the existing visitation conference at the end of the trial period. Endpoints include: Patient-reported (quality of life, anxiety and depression, self-efficacy), caregiver-reported ( caregiver burden, anxiety and depression, well-being) and patient healthcare use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • COPD
  • Exacerbation within the last year
  • Living in Høje Taastrup or Copenhagen
  • Cognitively relevant
  • ICECAP-SCM at least two scores of:
  • 1, 2
  • 1, 2
  • 1, 2
  • 1, 2
  • 1, 2, 3
  • 1, 2
  • 1, 2

Exclusion criteria

  • Dementia
  • Psychosis
  • Substance abuse
  • Hearing or speech impairment
  • Cancer
  • Receiving specialized palliative care or other similar interventions
  • Immediately dying

Treatment and study plan

Stepped care

Other

Graduated palliative cross-sectoral care

Usual Care

Other

Usual care at the outpatient respiratory clinic

Primary outcomes

  1. ICECAP-SCM

    Time frame: 6 months

Secondary outcomes

  1. ICECAP-SCM

    Time frame: 3 months

  2. ICECAP-SCM

    Time frame: 9 months

  3. ICECAP-SCM

    Time frame: 12 months

  4. HADS

    Time frame: 3

    Anxiety and depression

  5. HADS

    Time frame: 6

    Anxiety and depression

  6. HADS

    Time frame: 9 months

    Anxiety and depression

  7. HADS

    Time frame: 12 months

    Anxiety and depression

  8. GSE

    Time frame: 3 months

    General self-efficacy scale

  9. GSE

    Time frame: 6 months

    General self-efficacy scale

  10. GSE

    Time frame: 9 months

    General self-efficacy scale

  11. GSE

    Time frame: 12 months

    General self-efficacy scale

  12. Hospital admissions

    Time frame: 3 months

    • Proportion of patients with any hospital admission
    • Mean number of admissions per patient
    • Bed days
  13. Hospital admissions

    Time frame: 6 months

    • Proportion of patients with any hospital admission
    • Mean number of admissions per patient
    • Bed days
  14. Hospital admissions

    Time frame: 9 months

    • Proportion of patients with any hospital admission
    • Mean number of admissions per patient
    • Bed days
  15. Hospital admissions

    Time frame: 12 months

    • Proportion of patients with any hospital admission
    • Mean number of admissions per patient
    • Bed days
  16. Healthcare use, municipality

    Time frame: 3 months

  17. Healthcare use, municipality

    Time frame: 6 months

  18. Healthcare use, municipality

    Time frame: 9 months

  19. Healthcare use, municipality

    Time frame: 12 months

  20. Healthcare use, hospital

    Time frame: 3 months

  21. Healthcare use, hospital

    Time frame: 6 months

  22. Healthcare use, hospital

    Time frame: 9 months

  23. Healthcare use, hospital

    Time frame: 12 months

  24. Healthcare use, general practice

    Time frame: 3 months

  25. Healthcare use, general practice

    Time frame: 6 months

  26. Healthcare use, general practice

    Time frame: 9 months

  27. Healthcare use, general practice

    Time frame: 12 months

  28. Survival

    Time frame: 12 months

  29. SF12

    Time frame: 3 months

    Health-related quality of life

  30. SF12

    Time frame: 6 months

    Health-related quality of life

  31. SF12

    Time frame: 9 months

    Health-related quality of life

  32. SF12

    Time frame: 12 months

    Health-related quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Isabella Drachmann, MSc. in Psychology

CONTACT

[email protected]

+45 24 34 21 35

Kirstine Benthien, Ph.d.

CONTACT

[email protected]

+4531160453

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Acronym: GRACE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 13, 2025
Registry last updated
Dec 10, 2025

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.

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