COPD (Chronic Obstructive Pulmonary Disease)GRACENCT06967324
GRACE - Graduated Response for Advanced COPD With Enhanced Support
A study testing Stepped care in people with COPD (Chronic Obstructive Pulmonary Disease), run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Stepped care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- COPD
- Exacerbation within the last year
- Living in Høje Taastrup or Copenhagen
- Cognitively relevant
- ICECAP-SCM at least two scores of:
- 1, 2
Show all 12Show fewer
- 1, 2
- 1, 2
- 1, 2
- 1, 2, 3
- 1, 2
- 1, 2
Who cannot join
- Dementia
- Psychosis
- Substance abuse
- Hearing or speech impairment
- Cancer
- Receiving specialized palliative care or other similar interventions
- Immediately dying
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Isabella Drachmann, MSc. in Psychology contact
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital - Hvidovre
Hvidovre, 2650
Isabella Drachmann, MSc., +45 24 34 21 35, isabella.drachmann.camilleri@regionh.dk
Kirstine Benthien, Ph.D.
About this study
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.
Read the 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.
- Being tested
- Stepped care, Usual Care
- Keywords
- COPD, palliative care, cross-sectoral
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped careOther
Graduated palliative cross-sectoral care
Usual CareOther
Usual care at the outpatient respiratory clinic
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cross-sectoral stepped care with systematic needs assessment, advance care planning and virtual conferences Receives: Other: Stepped care; Other: Usual Care |
| Control | Active comparator | Care as usual at the outpatient respiratory clinic Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICECAP-SCM
Measured: 6 months
Secondary outcomes (32)
ICECAP-SCM
Measured: 3 months
ICECAP-SCM
Measured: 9 months
ICECAP-SCM
Measured: 12 months
HADS
Anxiety and depression
Measured: 3
HADS
Anxiety and depression
Measured: 6
HADS
Anxiety and depression
Measured: 9 months
HADS
Anxiety and depression
Measured: 12 months
GSE
General self-efficacy scale
Measured: 3 months
GSE
General self-efficacy scale
Measured: 6 months
GSE
General self-efficacy scale
Measured: 9 months
GSE
General self-efficacy scale
Measured: 12 months
Hospital admissions
- Proportion of patients with any hospital admission
- Mean number of admissions per patient
- Bed days
Measured: 3 months
Hospital admissions
- Proportion of patients with any hospital admission
- Mean number of admissions per patient
- Bed days
Measured: 6 months
Hospital admissions
- Proportion of patients with any hospital admission
- Mean number of admissions per patient
- Bed days
Measured: 9 months
Hospital admissions
- Proportion of patients with any hospital admission
- Mean number of admissions per patient
- Bed days
Measured: 12 months
Healthcare use, municipality
Measured: 3 months
Healthcare use, municipality
Measured: 6 months
Healthcare use, municipality
Measured: 9 months
Healthcare use, municipality
Measured: 12 months
Healthcare use, hospital
Measured: 3 months
Healthcare use, hospital
Measured: 6 months
Healthcare use, hospital
Measured: 9 months
Healthcare use, hospital
Measured: 12 months
Healthcare use, general practice
Measured: 3 months
Healthcare use, general practice
Measured: 6 months
Healthcare use, general practice
Measured: 9 months
Healthcare use, general practice
Measured: 12 months
Survival
Measured: 12 months
SF12
Health-related quality of life
Measured: 3 months
SF12
Health-related quality of life
Measured: 6 months
SF12
Health-related quality of life
Measured: 9 months
SF12
Health-related quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start7 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstine Skov Benthien, Copenhagen University Hospital, Hvidovre
- Investigators
- Kirstine Benthien, Ph.d., Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967324
- Sponsor's protocol ID
- H-25009646
- Acronym
- GRACE
- Status last verified
- Aug 2025
- First submitted
- 12 May 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRACE - Graduated Response for Advanced COPD With Enhanced Support
- ClinicalTrials.gov ID
- NCT06967324
- Acronym / sponsor ID
- GRACE / H-25009646
- Keywords
- COPD, palliative care, cross-sectoral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Stepped care, Other: Usual CareCross-sectoral stepped care with systematic needs assessment, advance care planning and virtual conferences |
| Control | Active comparator | Other: Usual CareCare as usual at the outpatient respiratory clinic |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- COPD
- Exacerbation within the last year
- Living in Høje Taastrup or Copenhagen
- Cognitively relevant
- ICECAP-SCM at least two scores of:
Key exclusion criteria (7 listed)
- Dementia
- Psychosis
- Substance abuse
- Hearing or speech impairment
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped careGraduated palliative cross-sectoral care | Other | Intervention |
| Usual CareUsual care at the outpatient respiratory clinic | Other | Control, Intervention |
Primary outcome
ICECAP-SCM
Time frame: 6 months
32 secondary outcomes
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
Hospital admissions
Time frame: 6 months
Hospital admissions
Time frame: 9 months
Hospital admissions
Time frame: 12 months
Healthcare use, municipality
Time frame: 3 months
Healthcare use, municipality
Time frame: 6 months
Healthcare use, municipality
Time frame: 9 months
Healthcare use, municipality
Time frame: 12 months
Healthcare use, hospital
Time frame: 3 months
Healthcare use, hospital
Time frame: 6 months
Healthcare use, hospital
Time frame: 9 months
Healthcare use, hospital
Time frame: 12 months
Healthcare use, general practice
Time frame: 3 months
Healthcare use, general practice
Time frame: 6 months
Healthcare use, general practice
Time frame: 9 months
Healthcare use, general practice
Time frame: 12 months
Survival
Time frame: 12 months
SF12
Time frame: 3 months
SF12
Time frame: 6 months
SF12
Time frame: 9 months
SF12
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabella Drachmann, MSc. in Psychology contact
Kirstine Benthien, Ph.d. principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped care in people with COPD (Chronic Obstructive Pulmonary Disease), run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Drachmann, MSc. in Psychology (+45 24 34 21 35, isabella.drachmann.camilleri@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICECAP-SCM (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.