Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Cross-sectoral stepped care with systematic needs assessment, advance care planning and virtual conferences |
|
| Control | Active Comparator | Care as usual at the outpatient respiratory clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped care | Other | Graduated palliative cross-sectoral care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ICECAP-SCM | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICECAP-SCM | 3 months | |
| ICECAP-SCM | 9 months | |
| ICECAP-SCM |
Not provided
Inclusion Criteria:
COPD
Exacerbation within the last year
Living in Høje Taastrup or Copenhagen
Cognitively relevant
ICECAP-SCM at least two scores of:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella Drachmann, MSc. in Psychology | Contact | +45 24 34 21 35 | isabella.drachmann.camilleri@regionh.dk | |
| Kirstine Benthien, Ph.d. | Contact | +4531160453 | Kirstine.skov.benthien.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirstine Benthien, Ph.d. | Copenhagen University Hospital, Hvidovre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Hvidovre | Recruiting | Hvidovre | 2650 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual Care |
| Other |
Usual care at the outpatient respiratory clinic |
|
| 12 months |
| HADS | Anxiety and depression | 3 |
| HADS | Anxiety and depression | 6 |
| HADS | Anxiety and depression | 9 months |
| HADS | Anxiety and depression | 12 months |
| GSE | General self-efficacy scale | 3 months |
| GSE | General self-efficacy scale | 6 months |
| GSE | General self-efficacy scale | 9 months |
| GSE | General self-efficacy scale | 12 months |
| Hospital admissions |
| 3 months |
| Hospital admissions |
| 6 months |
| Hospital admissions |
| 9 months |
| Hospital admissions |
| 12 months |
| Healthcare use, municipality | 3 months |
| Healthcare use, municipality | 6 months |
| Healthcare use, municipality | 9 months |
| Healthcare use, municipality | 12 months |
| Healthcare use, hospital | 3 months |
| Healthcare use, hospital | 6 months |
| Healthcare use, hospital | 9 months |
| Healthcare use, hospital | 12 months |
| Healthcare use, general practice | 3 months |
| Healthcare use, general practice | 6 months |
| Healthcare use, general practice | 9 months |
| Healthcare use, general practice | 12 months |
| Survival | 12 months |
| SF12 | Health-related quality of life | 3 months |
| SF12 | Health-related quality of life | 6 months |
| SF12 | Health-related quality of life | 9 months |
| SF12 | Health-related quality of life | 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |