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RecruitingNCT06967324GRACEUpdated Dec 10, 2025

GRACE - Graduated Response for Advanced COPD With Enhanced Support

An interventional study of Stepped care and Usual Care in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Copenhagen University Hospital, Hvidovre. Recruiting at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Copenhagen University Hospital, Hvidovre · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • COPD (Chronic Obstructive Pulmonary Disease)

Keywords

  • COPD
  • palliative care
  • cross-sectoral
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • COPD
  • Exacerbation within the last year
  • Living in Høje Taastrup or Copenhagen
  • Cognitively relevant

  • ICECAP-SCM at least two scores of:

    1. 1, 2
    2. 1, 2
    3. 1, 2
    4. 1, 2
    5. 1, 2, 3
    6. 1, 2
    7. 1, 2

Exclusion criteria

Exclusion Criteria:

  • Dementia
  • Psychosis
  • Substance abuse
  • Hearing or speech impairment
  • Cancer
  • Receiving specialized palliative care or other similar interventions
  • Immediately dying
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Intervention

    Cross-sectoral stepped care with systematic needs assessment, advance care planning and virtual conferences

    Other: Stepped care · Other: Usual Care

  • Active comparator
    Control

    Care as usual at the outpatient respiratory clinic

    Other: Usual Care

Interventions

  • OtherStepped care

    Graduated palliative cross-sectoral care

  • OtherUsual Care

    Usual care at the outpatient respiratory clinic

05

What researchers measure

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

    Anxiety and depression

    Time frame: 3

  5. HADS

    Anxiety and depression

    Time frame: 6

  6. HADS

    Anxiety and depression

    Time frame: 9 months

  7. HADS

    Anxiety and depression

    Time frame: 12 months

  8. GSE

    General self-efficacy scale

    Time frame: 3 months

  9. GSE

    General self-efficacy scale

    Time frame: 6 months

  10. GSE

    General self-efficacy scale

    Time frame: 9 months

  11. GSE

    General self-efficacy scale

    Time frame: 12 months

  12. Hospital admissions

    * Proportion of patients with any hospital admission * Mean number of admissions per patient * Bed days

    Time frame: 3 months

  13. Hospital admissions

    * Proportion of patients with any hospital admission * Mean number of admissions per patient * Bed days

    Time frame: 6 months

  14. Hospital admissions

    * Proportion of patients with any hospital admission * Mean number of admissions per patient * Bed days

    Time frame: 9 months

  15. Hospital admissions

    * Proportion of patients with any hospital admission * Mean number of admissions per patient * Bed days

    Time frame: 12 months

  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

    Health-related quality of life

    Time frame: 3 months

  30. SF12

    Health-related quality of life

    Time frame: 6 months

  31. SF12

    Health-related quality of life

    Time frame: 9 months

  32. SF12

    Health-related quality of life

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Copenhagen University Hospital - Hvidovre
    Hvidovre, 2650, Denmark
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06967324
Lead sponsor
Copenhagen University Hospital, Hvidovre
Responsible party
Kirstine Skov Benthien (Senior Researcher, associate professor, Copenhagen University Hospital, Hvidovre) — Principal investigator
First posted
May 13, 2025
Start date
Aug 7, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Dec 10, 2025

Study contacts

Isabella Drachmann, MSc. in Psychology
Contact
isabella.drachmann.camilleri@regionh.dk
+45 24 34 21 35
Kirstine Benthien, Ph.d.
Contact
Kirstine.skov.benthien.01@regionh.dk
+4531160453
Kirstine Benthien, Ph.d.
principal investigator · Copenhagen University Hospital, Hvidovre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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