GRACE - Graduated Response for Advanced COPD With Enhanced Support

Copenhagen University Hospital, Hvidovre

Status: Enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Other: Usual Care; Other: Stepped care

Study type: Interventional

Funder types: Other

Identifiers

NCT06967324

H-25009646

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

Cross-sectoral stepped care with systematic needs assessment, advance care planning and virtual conferences

Treatment:

Other: Stepped care

Other: Usual Care

Control

Active Comparator group

Description:

Care as usual at the outpatient respiratory clinic

Treatment:

Other: Usual Care