Graduated response with enhanced support for people with advanced COPD
GRACE - Graduated Response for Advanced COPD With Enhanced Support
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06967324 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hvidovre
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.