GRACE - Graduated Response for Advanced COPD With Enhanced Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stepped care, Usual Care.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Stepped care
Graduated palliative cross-sectoral care - Other Usual Care
Usual care at the outpatient respiratory clinic
Primary outcome measures
- ICECAP-SCM [Time frame: 6 months]
Secondary outcome measures (12)
- ICECAP-SCM [Time frame: 3 months]
- ICECAP-SCM [Time frame: 9 months]
- ICECAP-SCM [Time frame: 12 months]
- HADS [Time frame: 3]
- HADS [Time frame: 6]
- HADS [Time frame: 9 months]
- HADS [Time frame: 12 months]
- GSE [Time frame: 3 months]
- GSE [Time frame: 6 months]
- GSE [Time frame: 9 months]
- GSE [Time frame: 12 months]
- Hospital admissions [Time frame: 3 months]
Eligibility 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, 2
- 1, 2
- 1, 2
- 1, 2
- 1, 2, 3
- 1, 2
- 1, 2
Exclusion criteria
- Dementia
- Psychosis
- Substance abuse
- Hearing or speech impairment
- Cancer
- Receiving specialized palliative care or other similar interventions
- Immediately dying
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Copenhagen University Hospital - Hvidovre — Hvidovre
Identifiers
NCT: NCT06967324 · H-25009646