COPD Exacerbation AcuteCOPE-DNCT06242301
Is a Collective Person-centered Dialogue Intervention for Hospitalised COPD Patients Feasible?
A study testing The collective person-centered dialogue intervention in people with COPD Exacerbation Acute and Nutrition Poor, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation Acute, Nutrition Poor, Physical Inactivity
- What is being tested?
- The collective person-centered dialogue intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2024to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD
- Speak and understand Danish.
Who cannot join
- Patients in the end-of-life phase.
- Patients living in nursing homes.
- Patients with cognitive impairments avoiding participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Assessment of a Collective Person-centered Dialogue (COPE-D) Intervention for Patients Hospitalised with COPD Exacerbation
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:
Read more
- 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:
- Assess the patient's need for nutrition and physical activity support, both during and after hospitalisation using the dialogue tool.
- Develop an action plan for nutrition and physical activity support using the action plan template.
- The interdisciplinary team will provide, adjust, and document the nutritional and physical activity support provided by the action plan.
- 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.
- Being tested
- The collective person-centered dialogue intervention
- Keywords
- COPD, Nutrition, Physical activity, Person-centered, Dialogue
- Medical subject headings
- Malnutrition, Sedentary Behavior, Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The collective person-centered dialogue interventionOther
- Educate and train the interdisciplinary team and staff.
- Upon hospitalisation, the interdisciplinary team introduces an interactive dialogue tool to patients and their relatives. The tool is designed to facilitate a person-centered dialogue and assess the patients' needs, motivations, and challenges regarding eating and physical activity during hospitalization and in everyday settings.
- Following the needs assessment, the interdisciplinary team will introduce and initiate a personalised action plan based on a predefined template that includes suggestions for actions related to the needs assessment.
- Collaboratively, the interdisciplinary team, patients, and relatives evaluate and adjust the action plan, discussing relevant actions and potential community support for maintaining daily activities.
- Before discharge, discussions are guided by predefined questions. Patients receive a contact number for follow-up and information on oral nutritional supplementation prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| The COPE-D intervention | Other | Not described Receives: Other: The collective person-centered dialogue intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical uncertainties - An evaluation of the delivery of the needs assessment and the action plan
Following criteria are considered to evaluate the delivery of the needs assessment and the action plan:
- If less than 80 % receive the needs assessment based on the dialogue tool or the action plan based on the template, the intervention is considered non-feasible.
- If 80 to 90 % receive the needs assessment and the action plan, then actions to modify the intervention will be elaborated during the upcoming focus group interview with the interdisciplinary team. Any decision to modify the intervention will be based on the completed analysis of the feasibility.
- If more than 90 % receive the needs assessment and the action plan, then the delivery is determined as feasible without modifications.
Measured: 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.
Clinical uncertainties - An evaluation of the delivery of the provision actions provided by the action plan
Following criteria are considered to evaluate the delivery of the provision actions from the action plan:
- If less than 50 % of the actions planned in the action planner are provided, then the COPD support intervention is considered non-feasible.
- If less than 75 % of the actions planned in the action planner are provided, then actions to modify the intervention will be elaborated during the upcoming focus group interview.
The modification of the intervention will be based on the completed feasibility test.
- If 75 % or above of the actions planned in the action planner are provided, then the COPE-D intervention is considered feasible without modifications.
Measured: 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.
Clinical uncertainties - An evaluation of the patients and their relative acceptability of the intervention.
Following criteria are considered to evaluate the patients and their relative acceptability of the intervention.
- If less than 50 % of the patient responses contain a positive prompt, then the intervention is considered non-feasible.
- If between 50- 75 % of the patient responses contain a positive prompt, then actions to modify the intervention will be elaborated during the upcoming focus group interview.
Any decision to modify the intervention will be based on the completed analysis of the feasibility.
- If 75 % or above of the patient responses contain a positive prompt, then the COPE-D intervention is considered feasible without modifications.
Measured: 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.
Clinical uncertainties - An evaluation of the interdisciplinary team members acceptability of the intervention
The assessment will be measured qualitatively. Focus group interviews will be conducted using a semi-structured interview guide.
Measured: The measurement will be assessed after the intervention at week six
Procedural uncertainties - An evaluation of the patients willingness to participate
Following criteria are considered to evaluate the recruitment for paricipation in the intervention:
- If less than 30% are willing to participate in the intervention, then the intervention is considered not feasible.
- If recruitment falls within the range of 30% to 75%, modifications will be considered.
Determine contextual factors that may influence the recruitment process. Discuss in the focus group interviews with the interdisciplinary team and with the department managers about potential contextual factors that may influence the low recruitment rate.
- If 75% or more are recruited, the study is deemed feasible without modifications.
Measured: .Measurement will be taken during recruitment. Measurements will be taken four weeks after the beginning of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Jan 2024
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Danish Lung Association
- Responsible party
- Principal investigator, Tanja Sofie Hansen, Hvidovre University Hospital
- Investigators
- Tanja Sofie Hansen, MScN, Principal investigator, Region hIngrid Poulsen, Prof., Study chair, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242301
- Sponsor's protocol ID
- COPD dialogue - Feasibility
- Acronym
- COPE-D
- Status last verified
- Sep 2024
- First submitted
- 14 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of a Collective Person-centered Dialogue (COPE-D) Intervention for Patients Hospitalised with COPD Exacerbation
- ClinicalTrials.gov ID
- NCT06242301
- Acronym / sponsor ID
- COPE-D / COPD dialogue - Feasibility
- Keywords
- COPD, Nutrition, Physical activity, Person-centered, Dialogue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Danish Lung Association
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 5 Feb 2024 (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 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:
- Assess the patient's need for nutrition and physical activity support, both during and after hospitalisation using the dialogue tool.
- Develop an action plan for nutrition and physical activity support using the action plan template.
- The interdisciplinary team will provide, adjust, and document the nutritional and physical activity support provided by the action plan.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The COPE-D intervention | Other | Other: The collective person-centered dialogue intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with COPD
- Speak and understand Danish.
Key exclusion criteria (3 listed)
- Patients in the end-of-life phase.
- Patients living in nursing homes.
- Patients with cognitive impairments avoiding participation.
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 |
|---|---|---|
| The collective person-centered dialogue intervention* Educate and train the interdisciplinary team and staff. * Upon hospitalisation, the interdisciplinary team introduces an interactive dialogue tool to patients and their relatives. The tool is designed to facilitate a person-centered dialogue and assess the patients' needs, motivations, and challenges regarding eating and physical activity during hospitalization and in everyday settings. * Following the needs assessment, the interdisciplinary team will introduce and initiate a personalised action plan based on a predefined template that includes suggestions for actions related to the needs assessment. * Collaboratively, the interdisciplinary team, patients, and relatives evaluate and adjust the action plan, discussing relevant actions and potential community support for maintaining daily activities. * Before discharge, discussions are guided by predefined questions. Patients receive a contact number for follow-up and information on oral nutritional supplementation prescriptions. | Other | The COPE-D intervention |
Primary outcome
Clinical uncertainties - An evaluation of the delivery of the needs assessment and the action plan
Time frame: 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.
Following criteria are considered to evaluate the delivery of the needs assessment and the action plan: * If less than 80 % receive the needs assessment based on the dialogue tool or the action plan based on the template, the intervention is considered non-feasible. * If 80 to 90 % receive the needs assessment and the action plan, then actions to modify the intervention will be elaborated during the upcoming focus group interview with the interdisciplinary team. Any decision to modify the intervention will be based on the completed analysis of the feasibility. * If more than 90 % receive the needs assessment and the action plan, then the delivery is determined as feasible without modifications.
Clinical uncertainties - An evaluation of the delivery of the provision actions provided by the action plan
Time frame: 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.
Following criteria are considered to evaluate the delivery of the provision actions from the action plan: * If less than 50 % of the actions planned in the action planner are provided, then the COPD support intervention is considered non-feasible. * If less than 75 % of the actions planned in the action planner are provided, then actions to modify the intervention will be elaborated during the upcoming focus group interview. The modification of the intervention will be based on the completed feasibility test. • If 75 % or above of the actions planned in the action planner are provided, then the COPE-D intervention is considered feasible without modifications.
Clinical uncertainties - An evaluation of the patients and their relative acceptability of the intervention.
Time frame: 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.
Following criteria are considered to evaluate the patients and their relative acceptability of the intervention. * If less than 50 % of the patient responses contain a positive prompt, then the intervention is considered non-feasible. * If between 50- 75 % of the patient responses contain a positive prompt, then actions to modify the intervention will be elaborated during the upcoming focus group interview. Any decision to modify the intervention will be based on the completed analysis of the feasibility. • If 75 % or above of the patient responses contain a positive prompt, then the COPE-D intervention is considered feasible without modifications.
Clinical uncertainties - An evaluation of the interdisciplinary team members acceptability of the intervention
Time frame: The measurement will be assessed after the intervention at week six
The assessment will be measured qualitatively. Focus group interviews will be conducted using a semi-structured interview guide.
Procedural uncertainties - An evaluation of the patients willingness to participate
Time frame: .Measurement will be taken during recruitment. Measurements will be taken four weeks after the beginning of the intervention.
Following criteria are considered to evaluate the recruitment for paricipation in the intervention: * If less than 30% are willing to participate in the intervention, then the intervention is considered not feasible. * If recruitment falls within the range of 30% to 75%, modifications will be considered. Determine contextual factors that may influence the recruitment process. Discuss in the focus group interviews with the interdisciplinary team and with the department managers about potential contextual factors that may influence the low recruitment rate. • If 75% or more are recruited, the study is deemed feasible without modifications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tanja Sofie Hansen, MScN principal investigator
Region h
Ingrid Poulsen, Prof. study chair
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 The collective person-centered dialogue intervention in people with COPD Exacerbation Acute and Nutrition Poor, run by Hvidovre University Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical uncertainties - An evaluation of the delivery of the needs assessment and the action plan (time frame: 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.). The study lists 5 primary outcomes in all. 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 19 Sep 2024.