Clinical trial NCT06967324: GRACE - Graduated Response for Advanced COPD With Enhanced Support
Official title: GRACE - Graduated Response for Advanced COPD With Enhanced Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: COPD
palliative care
cross-sectoral
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* COPD
* Exacerbation within the last year
* Living in Høje Taastrup or Copenhagen
* Cognitively relevant
* Clinical Frailty scale 6+
* 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

Primary outcomes:
measure: ICECAP-SCM
timeFrame: 6 months
Secondary outcomes:
measure: ICECAP-SCM
timeFrame: 3 months
measure: ICECAP-SCM
timeFrame: 9 months
measure: ICECAP-SCM
timeFrame: 12 months
measure: HADS
timeFrame: 3
measure: HADS
timeFrame: 6
measure: HADS
timeFrame: 9 months
measure: HADS
timeFrame: 12 months
measure: GSE
timeFrame: 3 months
measure: GSE
timeFrame: 6 months
measure: GSE
timeFrame: 9 months
measure: GSE
timeFrame: 12 months
measure: Hospital admissions
timeFrame: 3 months
measure: Hospital admissions
timeFrame: 6 months
measure: Hospital admissions
timeFrame: 9 months
measure: Hospital admissions
timeFrame: 12 months
measure: Healthcare use, municipality
timeFrame: 3 months
measure: Healthcare use, municipality
timeFrame: 6 months
measure: Healthcare use, municipality
timeFrame: 9 months
measure: Healthcare use, municipality
timeFrame: 12 months
measure: Healthcare use, hospital
timeFrame: 3 months
measure: Healthcare use, hospital
timeFrame: 6 months
measure: Healthcare use, hospital
timeFrame: 9 months
measure: Healthcare use, hospital
timeFrame: 12 months
measure: Healthcare use, general practice
timeFrame: 3 months
measure: Healthcare use, general practice
timeFrame: 6 months
measure: Healthcare use, general practice
timeFrame: 9 months
measure: Healthcare use, general practice
timeFrame: 12 months
measure: Survival
timeFrame: 12 months
measure: SF12
timeFrame: 3 months
measure: SF12
timeFrame: 6 months
measure: SF12
timeFrame: 9 months
measure: SF12
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Kirstine Benthien, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: