ClinicalTrials.gg
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

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark — 34 open to participants now, 42 under way, 8 of them phase 3. Pulmonary Disease, Chronic Obstructive · Denmark.

Planned enrollment
137th of 209
100 · median 182
Started
2025
with 12 others
No phase
84 of 242
16 open now
Primary completion
2026-12
later than 13 of 41 live
Registered
226th of 242
by date
Lead sponsor
5 of 242
Copenhagen University Hospital, Hvidovre

Among the 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark, this one is the 137th largest by planned enrollment of the 209 interventional ones that give a count, is one of 13 that started in 2025, is one of 84 with no phase, reaches primary completion later than 13 of the 41 other live ones, and was the 226th registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

34 of the 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark are open now. Recruiting first, the newest first:

28 more — sign in →

All 34 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark, or all of them as a file.
02

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.

03

Conditions studied

  • COPD (Chronic Obstructive Pulmonary Disease)

Keywords

  • COPD
  • palliative care
  • cross-sectoral
04

Who can participate

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

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

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.

Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 16 months is below that.

Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

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

Registered
May 12, 2025
First posted
May 13, 2025
StartActual
Aug 7, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2027
Last update
Dec 10, 2025
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 Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion