Copenhagen University Hospital - Hvidovre
Hvidovre, 2650, Denmark
Location status: Recruiting
NCT Number: NCT06967324
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Hvidovre, 2650, Denmark
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Graduated palliative cross-sectoral care
Usual care at the outpatient respiratory clinic
Time frame: 6 months
Time frame: 3 months
Time frame: 9 months
Time frame: 12 months
Time frame: 3
Anxiety and depression
Time frame: 6
Anxiety and depression
Time frame: 9 months
Anxiety and depression
Time frame: 12 months
Anxiety and depression
Time frame: 3 months
General self-efficacy scale
Time frame: 6 months
General self-efficacy scale
Time frame: 9 months
General self-efficacy scale
Time frame: 12 months
General self-efficacy scale
Time frame: 3 months
Time frame: 6 months
Time frame: 9 months
Time frame: 12 months
Time frame: 3 months
Time frame: 6 months
Time frame: 9 months
Time frame: 12 months
Time frame: 3 months
Time frame: 6 months
Time frame: 9 months
Time frame: 12 months
Time frame: 3 months
Time frame: 6 months
Time frame: 9 months
Time frame: 12 months
Time frame: 12 months
Time frame: 3 months
Health-related quality of life
Time frame: 6 months
Health-related quality of life
Time frame: 9 months
Health-related quality of life
Time frame: 12 months
Health-related quality of life
Contact information is provided by the study sponsor or research team.
Isabella Drachmann, MSc. in Psychology
CONTACT
Kirstine Benthien, Ph.d.
CONTACT
Copenhagen University Hospital, Hvidovre
Other
Acronym: GRACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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