CopdNCT04860375
Multidisciplinary Management of Severe COPD
A study testing Multidisciplinary patient care in people with Copd and COPD Exacerbation, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Copd, COPD Exacerbation
- What is being tested?
- Multidisciplinary patient care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 22 Sep 2021to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged ≥40 years.
- Smokers or ex-smokers (≥10 pack-year).
- Prior hospitalization because of progressively worsening dyspnea (associated or not with increased cough and sputum, and or sputum purulence), with a clinically suspected diagnosis of exacerbations of COPD that prompt the discharging physician to refer the patient to the COPD Center.
- Signed informed concent form.
Who cannot join
- Presenting to the hospital for similar symptoms, which are not defined by the clinicians as suspected exacerbations of COPD, because of alternative diagnoses not related to patients with COPD (e.g., chest wall trauma, neurological disorders, sepsis, cancer and anemia).
- Already enrolled in other studies perceived to interfere with this protocol.
- In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis).
- Unable to comply with study procedures and follow-ups in the opinion of the Investigator (e.g., other severe diseases with short life expectancy or who make it impossible for the patients to participate into the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder).
- Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU.
- Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry disorders requiring specialized care.
- At the discretion of the recruiting clinician would not be able to be considered for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
COPD-Center
Gothenburg, VGR
Lowie Vanfleteren
Anna Lundborg
About this study
Official title: Longitudinal, Open Label, Clinical Trial Evaluating the Effectiveness of Detailed Phenotyping and Subsequent Multidisciplinary Management of Both COPD and Multimorbidity in Patients With COPD After a Hospitalization Due to Acute Exacerbation of COPD.
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases.
Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients.
This is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The "end of study" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.
- Conditions
- Copd, COPD Exacerbation
- Being tested
- Multidisciplinary patient care, Standard care
- Keywords
- COPD, Multidisciplinary management, COPD exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary patient careProcedure or surgery
A holistic, multidisciplinary, patient-centered care.
Standard careOther
Standard care in Sweden
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary, holistic and patient-centered care | Experimental | Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol (total 5 visits). Receives: Procedure: Multidisciplinary patient care |
| Standard care | Active comparator | The control group will be recruited from the Swedish Airway Register at the end of the study. Selection will be based on propensity score matching to the intervention group. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of hospitalizations
The aim is to investigate whether comprehensive care according to an individual plan (accurate diagnosis, assessment of severity, and multidisciplinary management of COPD patients referred to the COPD center after hospitalization caused by hospitalization due to acute exacerbation of COPD) will be associated with a decreased number of hospitalizations from all causes compared to a standard care.
Change in number of hospitalizations will be calculated by total number of hospitalizations from all causes per year.
Measured: Baseline and 3 years after baseline
Secondary outcomes (8)
Number of hospitalizations for COPD diagnosis
Change will be calculated by number of hospitalizations for COPD and compared to a total number of hospitalizations from other causes.
Measured: Baseline and 3 years after baseline
Length of hospitalization
Change in mean hospitalization time will be calculated by number of hospitalization days per year and in total study period.
Measured: Baseline and 3 years after baseline
Mortality
Change in all cause mortality will be measured by time to death (days, months or years).
Measured: Baseline and up to 3 years after baseline
Impact of COPD on patient's health
Change in disease-specific impact on health will be assessed by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points.
Measured: Baseline and 3 years after baseline
Dyspnea
Change in dyspnea will be measured by Modified Medical Research Council Dyspnea Scale (mMRC). The scale ranges 0 to 4 points, higher score indicating higher degree of disability that breathlessness poses on day-to-day activities.
Measured: Baseline and 3 years after baseline
Anxiety and depression
Change in anxiety and depression will be assessed by using the Hospital Anxiety and Depression Scale (HADS). HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >10 denotes anxiety or depression.
Measured: Baseline and 3 years after baseline
Sleepiness
Change in sleepiness will be measured by the Epworth Sleepiness Scale (ESS). The result is a sum of 8 item scores (0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life or their 'daytime sleepiness'.
Measured: Baseline and 3 years after baseline
Physical activity
Change in physical activity will be measured by 6-Minute Walking Test.
Measured: Baseline and 3 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start22 Sep 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, open label, cohort study using design of intervention and registries data. Eligible patients for intervention group will be recruited consecutively from patients referred to the COPD-Center at the Sahlgrenska University Hospital, after a hospital admission because of acute or progressive worsening dyspnea. The control group will be recruited from the Swedish Airway Register and selection will be based on propensity score matching. A total of 110 patients will be included in the intervention group and 220 in the control group.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lowie Vanfleteren, Vastra Gotaland Region
- Investigators
- Lowie Vanfleteren, Principal investigator, COPD-center, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860375
- Sponsor's protocol ID
- Care4COPD
- Status last verified
- May 2026
- First submitted
- 15 Apr 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal, Open Label, Clinical Trial Evaluating the Effectiveness of Detailed Phenotyping and Subsequent Multidisciplinary Management of Both COPD and Multimorbidity in Patients With COPD After a Hospitalization Due to Acute Exacerbation of COPD.
- ClinicalTrials.gov ID
- NCT04860375
- Acronym / sponsor ID
- Care4COPD
- Conditions
- Copd, COPD Exacerbation
- Keywords
- COPD, Multidisciplinary management, COPD exacerbation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Apr 2021 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases.
Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients.
This is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The "end of study" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, open label, cohort study using design of intervention and registries data. Eligible patients for intervention group will be recruited consecutively from patients referred to the COPD-Center at the Sahlgrenska University Hospital, after a hospital admission because of acute or progressive worsening dyspnea. The control group will be recruited from the Swedish Airway Register and selection will be based on propensity score matching. A total of 110 patients will be included in the intervention group and 220 in the control group.
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary, holistic and patient-centered care | Experimental | Procedure: Multidisciplinary patient careBased on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol (total 5 visits). |
| Standard care | Active comparator | Other: Standard careThe control group will be recruited from the Swedish Airway Register at the end of the study. Selection will be based on propensity score matching to the intervention group. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, aged ≥40 years.
- Smokers or ex-smokers (≥10 pack-year).
- Prior hospitalization because of progressively worsening dyspnea (associated or not with increased cough and sputum, and or sputum purulence), with a clinically suspected diagnosis of exacerbations of COPD that prompt the discharging physician to refer the patient to the COPD Center.
- Signed informed concent form.
Key exclusion criteria (7 listed)
- Presenting to the hospital for similar symptoms, which are not defined by the clinicians as suspected exacerbations of COPD, because of alternative diagnoses not related to patients with COPD (e.g., chest wall trauma, neurological disorders, sepsis, cancer and anemia).
- Already enrolled in other studies perceived to interfere with this protocol.
- In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis).
- Unable to comply with study procedures and follow-ups in the opinion of the Investigator (e.g., other severe diseases with short life expectancy or who make it impossible for the patients to participate into the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder).
- Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU.
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 |
|---|---|---|
| Multidisciplinary patient careA holistic, multidisciplinary, patient-centered care. | Procedure or surgery | Multidisciplinary, holistic and patient-centered care |
| Standard careStandard care in Sweden | Other | Standard care |
Primary outcome
Total number of hospitalizations
Time frame: Baseline and 3 years after baseline
The aim is to investigate whether comprehensive care according to an individual plan (accurate diagnosis, assessment of severity, and multidisciplinary management of COPD patients referred to the COPD center after hospitalization caused by hospitalization due to acute exacerbation of COPD) will be associated with a decreased number of hospitalizations from all causes compared to a standard care. Change in number of hospitalizations will be calculated by total number of hospitalizations from all causes per year.
8 secondary outcomes
Number of hospitalizations for COPD diagnosis
Time frame: Baseline and 3 years after baseline
Length of hospitalization
Time frame: Baseline and 3 years after baseline
Mortality
Time frame: Baseline and up to 3 years after baseline
Impact of COPD on patient's health
Time frame: Baseline and 3 years after baseline
Dyspnea
Time frame: Baseline and 3 years after baseline
Anxiety and depression
Time frame: Baseline and 3 years after baseline
Sleepiness
Time frame: Baseline and 3 years after baseline
Physical activity
Time frame: Baseline and 3 years after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
Lowie Vanfleteren principal investigator
COPD-center, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary patient care in people with Copd and COPD Exacerbation, run by Vastra Gotaland Region at 1 site in Sweden.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lowie Vanfleteren (0046736601730, lowie.vanfleteren@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of hospitalizations (time frame: Baseline and 3 years after baseline). 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 14 May 2026.