Graduated response with enhanced support for people with advanced COPD
Official title: GRACE - Graduated Response for Advanced COPD With Enhanced Support
Run by Copenhagen University Hospital, Hvidovre · NCT06967324 · Data updated 2026-11-12
This project will try a stepped enhanced-support program—regular needs checks, advance care planning, and cross-sector virtual conferences—for people with advanced COPD to see if it improves quality of life and use of health services.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Status | Recruiting |
| Started | August 7, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT06967324 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are community-dwelling people with COPD who had an exacerbation in the past year, live in Høje Taastrup or Copenhagen, are registered with the Hvidovre Outpatient Respiratory Clinic, and meet the study's cognitive and capability screening criteria.
✕Probably not a fit
Patients with dementia, psychosis, substance abuse, major hearing or speech impairment, active cancer, those already receiving specialized palliative care, or who are imminently dying are excluded and unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-blinded, randomized controlled pilot comparing a GRACE model of stepped palliative-style support to usual care in 100 community-dwelling patients with advanced COPD and their caregivers. Participants are randomized 1:1 with block randomization and stratification by municipality to ensure feasibility data from Høje Taastrup and Copenhagen. The intervention includes systematic needs assessment, advance care planning, and cross-sector virtual conferences, while the control group receives usual care and is offered assessment at trial end. Endpoints include patient-reported quality of life, anxiety and depression, self-efficacy, caregiver burden and well-being, and measures of healthcare use.
Why it matters
Potential benefit: If successful, the approach could improve patients' quality of life and caregiver well-being while reducing unplanned healthcare use by matching levels of support to need.
How similar studies have gone: Previous pilot and integration studies of palliative approaches and advance care planning in COPD have produced mixed but promising signals for improving quality of life and reducing hospital use, so this trial builds on preliminary evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: * Dementia * Psychosis * Substance abuse * Hearing or speech impairment * Cancer * Receiving specialized palliative care or other similar interventions * Immediately dying
Where it's running
-
Copenhagen University Hospital - Hvidovre
Hvidovre, Denmark Recruiting
Study contacts
- Principal investigator: Kirstine Benthien, Ph.d. — Copenhagen University Hospital, Hvidovre
- Study coordinator: Isabella Drachmann, MSc. in Psychology
- Email: isabella.drachmann.camilleri@regionh.dk
- Phone: +45 24 34 21 35
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.