NCT06967324

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Aug 2025Jun 2027

First Submitted

Initial submission to the registry

May 12, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 7, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 10, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

May 12, 2025

Last Update Submit

December 9, 2025

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPDpalliative carecross-sectoral

Outcome Measures

Primary Outcomes (1)

  • ICECAP-SCM

    6 months

Secondary Outcomes (32)

  • ICECAP-SCM

    3 months

  • ICECAP-SCM

    9 months

  • ICECAP-SCM

    12 months

  • HADS

    3

  • HADS

    6

  • +27 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Stepped careOther: Usual Care

Control

ACTIVE COMPARATOR

Care as usual at the outpatient respiratory clinic

Other: Usual Care

Interventions

Stepped careOTHER

Graduated palliative cross-sectoral care

Intervention
Usual CareOTHER

Usual care at the outpatient respiratory clinic

ControlIntervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • COPD
  • Exacerbation within the last year
  • Living in Høje Taastrup or Copenhagen
  • Cognitively relevant
  • ICECAP-SCM at least two scores of:
  • , 2
  • , 2
  • , 2
  • , 2
  • , 2, 3
  • , 2
  • , 2

You may not qualify if:

  • Dementia
  • Psychosis
  • Substance abuse
  • Hearing or speech impairment
  • Cancer
  • Receiving specialized palliative care or other similar interventions
  • Immediately dying

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital - Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kirstine Benthien, Ph.d.

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Drachmann, MSc. in Psychology

CONTACT

+45 24 34 21 35isabella.drachmann.camilleri@regionh.dk

Kirstine Benthien, Ph.d.

CONTACT

+4531160453Kirstine.skov.benthien.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, associate professor

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 13, 2025

Study Start

August 7, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

December 10, 2025

Record last verified: 2025-08

Locations

DK(1)