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GRACE - Graduated Response for Advanced COPD With Enhanced Support

GRACE - Graduated Response for Advanced COPD With Enhanced Support

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06967324
Acronym
GRACE
Enrollment
100
Registered
2025-05-13
Start date
2025-08-07
Completion date
2027-06-30
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD, palliative care, cross-sectoral

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.

Interventions

Graduated palliative cross-sectoral care

OTHERUsual Care

Usual care at the outpatient respiratory clinic

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frame
ICECAP-SCM6 months

Secondary

MeasureTime frameDescription
HADS3Anxiety and depression
GSE3 monthsGeneral self-efficacy scale
Hospital admissions3 months* Proportion of patients with any hospital admission * Mean number of admissions per patient * Bed days
Healthcare use, municipality3 months
ICECAP-SCM3 months
Healthcare use, general practice3 months
Survival12 months
SF123 monthsHealth-related quality of life
Healthcare use, hospital3 months

Countries

Denmark

Contacts

Primary ContactIsabella Drachmann, MSc. in Psychology
isabella.drachmann.camilleri@regionh.dk+45 24 34 21 35
Backup ContactKirstine Benthien, Ph.d.
Kirstine.skov.benthien.01@regionh.dk+4531160453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026