Chronic Obstructive Pulmonary Disease (COPD)NCT04301505
Improvement in COPD Elderly Patients Health: Study Protocol
A study testing Intervention 1 and Intervention 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz at 1 site in Poland.
Trial summary
Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Intervention 1 and Intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,520 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2020to 31 Mar 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10).
- Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records
Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. We have developed an educational program based on a checklist to assist general practitioners in managing COPD patients. The results of this trial based on electronic health records from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist, will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care and patient's quality of life.
Read the detailed description
This study is the three-arm cluster controlled randomized trial (CRT) with the patients nested within practices. The effectiveness of Checklist in reduction of COPD exacerbations health outcomes in COPD patients after 2 interventions will be evaluated and compared to that of usual care. The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care.
- Being tested
- Intervention 1, Intervention 2
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), elderly, exacerbation of COPD, prevalence, checklist, randomized controlled trial, electronic health records
- 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.
Intervention 1Other
Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.
Intervention 2Other
The same checklist will be delivered at the beginning of the study and repeated after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Usual care. |
| Intervention 1 | Other | COPD management checklist will be delivered at the beginning of the study. Receives: Other: Intervention 1 |
| Intervention 2 | Other | COPD management checklist will be delivered at the beginning of the study and repeated after 6 months. Receives: Other: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.
Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year.
Measured: 12 months
Secondary outcomes (1)
The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention.
Variables from BIG DATA databases, electronic health records (EHR) associated with checklist will be used to assess patients' health outcomes.
The effect of the educational intervention will be evaluated using logistic 2-level regression analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Mar 2020
- Primary completion28 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor
- Investigators
- Maciek Godycki-Cwirko, Prof., Principal investigator, Centre for Family and Community Medicine, Medical Univeristy of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301505
- Sponsor's protocol ID
- 2016/21/B/NZ7/02052
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kowalczyk A, Zakowska I, Andrzejewska E, Kosiek K, Godycki-Cwirko M. A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records. Trials. 2021 Feb 25;22(1):161. doi: 10.1186/s13063-021-05103-0.
PubMed 33632282
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records
- ClinicalTrials.gov ID
- NCT04301505
- Acronym / sponsor ID
- 2016/21/B/NZ7/02052
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), elderly, exacerbation of COPD, prevalence, checklist, randomized controlled trial, electronic health records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,520 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Mar 2020 (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.
Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. We have developed an educational program based on a checklist to assist general practitioners in managing COPD patients. The results of this trial based on electronic health records from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist, will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care and patient's quality of life.
Detailed description
This study is the three-arm cluster controlled randomized trial (CRT) with the patients nested within practices. The effectiveness of Checklist in reduction of COPD exacerbations health outcomes in COPD patients after 2 interventions will be evaluated and compared to that of usual care. The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Usual care. |
| Intervention 1 | Other | Other: Intervention 1COPD management checklist will be delivered at the beginning of the study. |
| Intervention 2 | Other | Other: Intervention 2COPD management checklist will be delivered at the beginning of the study and repeated after 6 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10).
- Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intervention 1Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly. | Other | Intervention 1 |
| Intervention 2The same checklist will be delivered at the beginning of the study and repeated after 6 months. | Other | Intervention 2 |
Primary outcome
The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.
Time frame: 12 months
Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year.
1 secondary outcome
The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention.
Time frame: 12 months
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 22 Feb 2023.
- Derived from this study: PubMed 33632282Kowalczyk A, Zakowska I, Andrzejewska E, Kosiek K, Godycki-Cwirko M. A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records. Trials. 2021 Feb 25;22(1):161. doi: 10.1186/s13063-021-05103-0.
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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.
Maciek Godycki-Cwirko, Prof. principal investigator
Centre for Family and Community Medicine, Medical Univeristy of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz at 1 site in Poland.
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 1 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 22 Feb 2023. 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 Poland. 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?
The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301505, which also lists 1 linked publication.
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 22 Feb 2023.