COPD (Chronic Obstructive Pulmonary Disease)NCT07104136
Improving Adherence to COPD Treatments in Primary Care
A study testing COPD-care seminar in people with COPD (Chronic Obstructive Pulmonary Disease) and Adherence to Care, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Adherence to Care
- What is being tested?
- COPD-care seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2025to 20 May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care physicians
- Have at least 18 COPD patients in his unit as documented in medical records
Who cannot join
- Refusal to sign informed consent to participate in the study.
- Less than 1-year projection of employment in current clinic.
- Prior completion of a course in motivational interviewing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improvement of Adherence to Treatment Among COPD Patients in Primary Care by Physician-directed Intervention
The goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD).
The main questions it aims to answer are:
Read more
- Does the training program help patients with COPD take their medications more regularly?
- Does it reduce the number of COPD flare-ups (exacerbations)?
- Does it improve how well doctors follow current treatment guidelines for COPD?
In this study:
- Primary care doctors will be randomly assigned to either receive the training or continue their usual care without intervention.
- The training includes updated information about COPD, a workshop on inhaler use, and a course on motivational interviewing (a method to support behavior change)
- The care of their patients with COPD will be reviewed over 12 months to see if the program made a difference in medication use, flare-ups, and other outcomes.
Read the detailed description
The investigators hypothesize that a primary care physician-directed intervention, consisting of a seminar with up-to-date professional guidance and motivational interviewing course, would result in patients' higher adherence to treatment, improved care, and fewer COPD exacerbations.
The study aims:
- To evaluate the effect of specific COPD patient centric educational program for primary care physicians on adherence to recommended therapy.
- To evaluate the effect of specific COPD patient centric educational program for primary care physicians on the number of moderate and severe COPD exacerbations.
This is a two-arm, parallel, randomized controlled trial conducted in a primary care setting, involving primary care physicians. All physicians will sign an informed consent form to participate.
The study will include two groups:
- Intervention Group - Twenty primary care physicians will be recruited. After inclusion and signing an informed consent, all physicians will participate in a two-day seminar. The seminar will include: up-to-date professional guidance on COPD management, an inhalers workshop and a course of motivational interview. The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months.
- Control Group - Twenty primary care physicians, matched to the intervention group by sociodemographic area and number of COPD patients in past year.
The effect of the intervention will be assessed based on the outcomes of all COPD patients that visited one of the physicians in the intervention/control groups during the first 6 months after study initiation. These patients will be identified retrospectively from medical charts. Assessment of patient care and outcomes will be analyzed retrospectively, 18 months after study initiation (end of study), addressing each patient's first 12 months from first relevant clinic visit.
Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
COPD medication adherence rates vary by geographic location but are usually around 25-30%. Based on previous research, the investigators conservatively assume that our intervention will lead to an absolute 17% increase in adherence during the 12 months from first follow-up. Considering the above, to achieve an alpha of 0.05 and a power of 80%, there is a need for 127 patients in each group. Given that participating primary care physicians must have seen at least 18 individual COPD patients in the past year, and assuming a similar rate of visits during the follow-up period, along with a 15-20% loss-to-follow-up due to changes in the treating physician, the investigators estimate that 20 primary care physicians will be needed in each group.
- Being tested
- COPD-care seminar
- Keywords
- COPD, Primary care, Motivational interviewing, Inhalers
- 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.
COPD-care seminarBehavioural
A two day seminar which will include:
Lectures:
Understanding COPD and Current Guidelines COPD pathophysiology. Review of the latest GOLD guidelines and treatment strategies Hands-on Session: Inhaler Technique and Device Selection Practical demonstration of different inhaler devices. Evaluating patient inspiratory effort and selecting suitable devices. Understanding advantages of each device and molecule. Cardiovascular diseases in COPD - real-world evidence, how to identify at-risk patients, and intervention.
Motivational interview seminar- On line pre-course lectures about the theory behind motivational interview. Two workshops for simulation and practice of the technic through clinical cases with relevance to COPD patients including smoking cessation counseling techniques.
Panel Discussion: Multidisciplinary Approach to COPD Management Involving respiratory specialists, physiotherapists, and primary care physicians.
Discussion on referral practices and collaborative care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the study, primary care physicians assigned to the intervention group will participate in a two-day seminar led by senior pulmonology specialists and family medicine specialists. The seminar will cover the following topic: Understanding COPD and current guidelines, inhaler technique and device selection, cardiovascular diseases in patients with COPD and possible interventions, motivational interview seminar, and two workshops for simulation and practice.
The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months. Receives: Behavioral: COPD-care seminar |
| Control | No intervention | Primary care physicians that will be included without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to COPD-related inhalers
Change in inhaler adherence from first clinic visit after trial initiation. Measured by the purchase of prescribed COPD inhalers and compared with the control group. The primary outcome will be assessed using the Proportion of Days Covered (PDC) method, calculated as the percentage of days a patient has medication available over the observation period. This outcome will be comapred between the intervention and control groups
Measured: From first patient visit after study initiation to 12 months after.
Secondary outcomes (8)
Change in adherence to inhaler therapy pre-post study
Change in inhaler adherence among COPD patients of primary care physicians in the 12 months prior and after inclusion, measured by the purchase of prescribed COPD medications and compared with the control group.
Measured: From first patient visit after study initiation to 12 months after.
Non-inhaler medications adherence pre-post study
Non-inhaler medication adherence in the 12 months prior and after inclusion, measured by the purchase of prescribed COPD medications and compared with the control group.
Measured: From first patient visit after study initiation to 12 months after.
Non-inhaler medication adherence
Non-inahler medication adherence from first clinic visit after study initiation, measured by the purchase of prescribed COPD medications and compared with the control group.
Measured: From first patient visit after study initiation to 12 months after.
Annualized rate of moderate or severe COPD exacerbations
The difference in the annualized rate of moderate or severe COPD exacerbations between the intervention and control groups from first clinic visit after trial initiation. Moderate exacerbations are defined as those requiring treatment with systemic glucocorticoids, antibiotics, or both. Severe exacerbations are defined as those resulting in hospitalization or emergency medical care.
Measured: From first patient visit after study initiation to 12 months after.
All-cause mortality
Incidence of all-cause mortality between the intervention and control
Measured: From first patient visit after study initiation to 12 months after.
Cardiovascular events
The rate of patients with new cardiovascular events, including myocardial infarction, ischemic stroke, heart failure exacerbation leading to hospital, and cardiovascular-related mortality.
Measured: From first patient visit after study initiation to 12 months after.
Guideline-based treatment
The percentage of patients at study end with inhaler therapy which meet the standard of care, as defined by the GOLD guidelines between the intervention and control groups
Measured: From first patient visit after study initiation to 12 months after.
Physician knowledge on COPD
Evaluation of physicians knowledge about COPD and a questionnaire assessing whether, in the physician's opinion, the intervention has increased their knowledge and ability to treat patients with chronic obstructive pulmonary disease.
Measured: From first patient visit after study initiation to 12 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start20 Nov 2025
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
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 COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104136
- Sponsor's protocol ID
- 0195-24-COM1
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might not be share due to limitations from the IRB committee
Publications
Martinez FJ, Thomashow B, Sapir T, Simone L, Carter J, Han M. Does Evaluation and Management of COPD Follow Therapeutic Strategy Recommendations? Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):230-242. doi: 10.15326/jcopdf.2020.0175.
PubMed 33610138
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Adherence to Treatment Among COPD Patients in Primary Care by Physician-directed Intervention
- ClinicalTrials.gov ID
- NCT07104136
- Acronym / sponsor ID
- 0195-24-COM1
- Keywords
- COPD, Primary care, Motivational interviewing, Inhalers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Clalit Health Services
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 5 Aug 2025 (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 goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD).
The main questions it aims to answer are:
- Does the training program help patients with COPD take their medications more regularly?
- Does it reduce the number of COPD flare-ups (exacerbations)?
- Does it improve how well doctors follow current treatment guidelines for COPD?
In this study:
- Primary care doctors will be randomly assigned to either receive the training or continue their usual care without intervention.
- The training includes updated information about COPD, a workshop on inhaler use, and a course on motivational interviewing (a method to support behavior change)
- The care of their patients with COPD will be reviewed over 12 months to see if the program made a difference in medication use, flare-ups, and other outcomes.
Detailed description
The investigators hypothesize that a primary care physician-directed intervention, consisting of a seminar with up-to-date professional guidance and motivational interviewing course, would result in patients' higher adherence to treatment, improved care, and fewer COPD exacerbations.
The study aims:
- To evaluate the effect of specific COPD patient centric educational program for primary care physicians on adherence to recommended therapy.
- To evaluate the effect of specific COPD patient centric educational program for primary care physicians on the number of moderate and severe COPD exacerbations.
This is a two-arm, parallel, randomized controlled trial conducted in a primary care setting, involving primary care physicians. All physicians will sign an informed consent form to participate.
The study will include two groups:
- Intervention Group - Twenty primary care physicians will be recruited. After inclusion and signing an informed consent, all physicians will participate in a two-day seminar. The seminar will include: up-to-date professional guidance on COPD management, an inhalers workshop and a course of motivational interview. The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months.
- Control Group - Twenty primary care physicians, matched to the intervention group by sociodemographic area and number of COPD patients in past year.
The effect of the intervention will be assessed based on the outcomes of all COPD patients that visited one of the physicians in the intervention/control groups during the first 6 months after study initiation. These patients will be identified retrospectively from medical charts. Assessment of patient care and outcomes will be analyzed retrospectively, 18 months after study initiation (end of study), addressing each patient's first 12 months from first relevant clinic visit.
Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
COPD medication adherence rates vary by geographic location but are usually around 25-30%. Based on previous research, the investigators conservatively assume that our intervention will lead to an absolute 17% increase in adherence during the 12 months from first follow-up. Considering the above, to achieve an alpha of 0.05 and a power of 80%, there is a need for 127 patients in each group. Given that participating primary care physicians must have seen at least 18 individual COPD patients in the past year, and assuming a similar rate of visits during the follow-up period, along with a 15-20% loss-to-follow-up due to changes in the treating physician, the investigators estimate that 20 primary care physicians will be needed in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: COPD-care seminarIn the study, primary care physicians assigned to the intervention group will participate in a two-day seminar led by senior pulmonology specialists and family medicine specialists. The seminar will cover the following topic: Understanding COPD and current guidelines, inhaler technique and device selection, cardiovascular diseases in patients with COPD and possible interventions, motivational interview seminar, and two workshops for simulation and practice. The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months. |
| Control | No intervention | –Primary care physicians that will be included without any 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)
- Primary care physicians
- Have at least 18 COPD patients in his unit as documented in medical records
Key exclusion criteria (3 listed)
- Refusal to sign informed consent to participate in the study.
- Less than 1-year projection of employment in current clinic.
- Prior completion of a course in motivational interviewing.
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 |
|---|---|---|
| COPD-care seminarA two day seminar which will include: Lectures: Understanding COPD and Current Guidelines COPD pathophysiology. Review of the latest GOLD guidelines and treatment strategies Hands-on Session: Inhaler Technique and Device Selection Practical demonstration of different inhaler devices. Evaluating patient inspiratory effort and selecting suitable devices. Understanding advantages of each device and molecule. Cardiovascular diseases in COPD - real-world evidence, how to identify at-risk patients, and intervention. Motivational interview seminar- On line pre-course lectures about the theory behind motivational interview. Two workshops for simulation and practice of the technic through clinical cases with relevance to COPD patients including smoking cessation counseling techniques. Panel Discussion: Multidisciplinary Approach to COPD Management Involving respiratory specialists, physiotherapists, and primary care physicians. Discussion on referral practices and collaborative care. | Behavioural | Intervention |
Primary outcome
Adherence to COPD-related inhalers
Time frame: From first patient visit after study initiation to 12 months after.
Change in inhaler adherence from first clinic visit after trial initiation. Measured by the purchase of prescribed COPD inhalers and compared with the control group. The primary outcome will be assessed using the Proportion of Days Covered (PDC) method, calculated as the percentage of days a patient has medication available over the observation period. This outcome will be comapred between the intervention and control groups
8 secondary outcomes
Change in adherence to inhaler therapy pre-post study
Time frame: From first patient visit after study initiation to 12 months after.
Non-inhaler medications adherence pre-post study
Time frame: From first patient visit after study initiation to 12 months after.
Non-inhaler medication adherence
Time frame: From first patient visit after study initiation to 12 months after.
Annualized rate of moderate or severe COPD exacerbations
Time frame: From first patient visit after study initiation to 12 months after.
All-cause mortality
Time frame: From first patient visit after study initiation to 12 months after.
Cardiovascular events
Time frame: From first patient visit after study initiation to 12 months after.
Guideline-based treatment
Time frame: From first patient visit after study initiation to 12 months after.
Physician knowledge on COPD
Time frame: From first patient visit after study initiation to 12 months after.
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 5 Mar 2026.
- Background: PubMed 33610138Martinez FJ, Thomashow B, Sapir T, Simone L, Carter J, Han M. Does Evaluation and Management of COPD Follow Therapeutic Strategy Recommendations? Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):230-242. doi: 10.15326/jcopdf.2020.0175.
- Individual participant dataSharing planned: No. IPD might not be share due to limitations from the IRB committee
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD-care seminar in people with COPD (Chronic Obstructive Pulmonary Disease) and Adherence to Care, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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: enrolling by invitation, as of the sponsor's last update on 5 Mar 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 Israel. 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?
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?
Adherence to COPD-related inhalers (time frame: From first patient visit after study initiation to 12 months after.). 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 NCT07104136, 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 5 Mar 2026.