Clinical trial NCT06242301: Is a Collective Person-centered Dialogue Intervention for Hospitalised COPD Patients Feasible?
Official title: Feasibility Assessment of a Collective Person-centered Dialogue (COPE-D) Intervention for Patients Hospitalised with COPD Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation Acute
Nutrition Poor
Physical Inactivity
Relatives
Keywords: COPD
Nutrition
Physical activity
Person-centered
Dialogue
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Danish Lung Association
First posted: 2024-02-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this mixed methods trial is to investigate the feasibility of a collective person-centred dialogue (COPE-D) intervention delivered by an interdisciplinary team for a population of patients hospitalised and diagnosed with COPD and their relatives.

The main questions it aims to answer are:

* The clinical uncertainties: What components of the COPE-D intervention are delivered to the included patients? (The data will be collected from the patient's journal record)
* The clinical uncertainties: How acceptable is the COPE-D intervention for the patients, relatives, and the interdisciplinary team? (Answered by patient and relative interviews with a structured interview guide before discharge and 14 days after hospitalisation, and by the interdisciplinary team using focus-group interviews after the intervention enrolment).
* The procedural uncertainties: Are the patients willing to engage in the trial? (Estimated by the inclusion rate).

The interdisciplinary team will be instructed to deliver and document the COPE-D intervention. The primary focus of COPE-D intervention is to prepare and enhance the patient's and relative's ability to regain their everyday life after discharge. The COPE-D intervention includes a dialogue tool based on a needs assessment, an action plan template, and a patient guide that prepares for discharge.

The interdisciplinary team will collaborate with COPD patients and their relatives to:

1. Assess the patient's need for nutrition and physical activity support, both during and after hospitalisation using the dialogue tool.
2. Develop an action plan for nutrition and physical activity support using the action plan template.
3. The interdisciplinary team will provide, adjust, and document the nutritional and physical activity support provided by the action plan.
4. Prior to discharge, patients and their relatives are given a discharge guide with pre-defined questions to ask healthcare professionals, a contact telephone number to the outpatient clinic for follow-up if needed, and information about prescriptions for oral nutritional supplementation.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD
* Speak and understand Danish.

Exclusion Criteria:

* Patients in the end-of-life phase.
* Patients living in nursing homes.
* Patients with cognitive impairments avoiding participation.

Primary outcomes:
measure: Clinical uncertainties - An evaluation of the delivery of the needs assessment and the action plan
timeFrame: Measurements will be taken at one time point for each participant prior to discharge. Measurements will be taken four weeks after the beginning of the intervention.
measure: Clinical uncertainties - An evaluation of the delivery of the provision actions provided by the action plan
timeFrame: Measurements will be taken at one time point for each participant prior to discharge. Measurements will be taken four weeks after the beginning of the intervention.
measure: Clinical uncertainties - An evaluation of the patients and their relative acceptability of the intervention.
timeFrame: Measurements will be taken at one time point for each participant prior to discharge. Measurements will be taken four weeks after the beginning of the intervention.
measure: Clinical uncertainties - An evaluation of the interdisciplinary team members acceptability of the intervention
timeFrame: The measurement will be assessed after the intervention at week six
measure: Procedural uncertainties - An evaluation of the patients willingness to participate
timeFrame: .Measurement will be taken during recruitment. Measurements will be taken four weeks after the beginning of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Amager
Study officials:
affiliation: Region h
name: Tanja Sofie Hansen, MScN
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital, Hvidovre
name: Ingrid Poulsen, Prof.
role: STUDY_CHAIR
References: