TelehealthNCT06477328
Evaluating Chronic Obstructive Pulmonary Disease (COPD) Patients' Treatment Compliance and Quality of Life Via Telemedicine
A study testing Telemedicine in people with Telehealth and Copd, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Telehealth, Copd
- What is being tested?
- Telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 15 Oct 2023
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed with COPD according to Global Initiative for Obstructive Lung Disease (GOLD)
- GOLD spirometric grade 3-4
- At least one hospital admission in the past year
- Acceptable score on the Mini-Mental State Examination
- Residing in Ankara
- Patient or caregiver must understand the process and be able to provide clear information
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- Medical records and laboratory test results must be accessible to healthcare professionals
- Patient must have access to prescribed medications
- Comorbidities outside of the lungs are included
Who cannot join
- Patients diagnosed with asthma
- Patients with lung cancer
- Patients with combined pulmonary fibrosis and emphysema
- Patients with active infections such as pneumonia or COVID-19
- Patients being followed for COPD without spirometry
- Patients with low cognitive function as determined by the Mini-Mental State Examination
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- Patients who do not consent to participate in the study
- Patients lacking adequate social support
- Patients with COPD grade 1-2
- Patients with no hospital admissions in the past year
- Patients diagnosed with psychotic disorders
- Patients residing outside of Ankara
- Patients enrolled in inpatient or supervised outpatient rehabilitation programs
- Patients unable to use telemedicine devices or without a caregiver to assist
- Patients and caregivers having difficulty providing information
- Patients without internet access or video call capabilities at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Compliance of Patients Diagnosed With Chronic Obstructive Pulmonary Disease And Their Quality of Life After Follow-up: Evaluation Via Telemedicine
The Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare provided face-to-face.
- Conditions
- Telehealth, Copd
- Being tested
- Telemedicine
- Keywords
- telemedicine, copd, inhaler adherence, inhaler technique
- 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.
TelemedicineProcedure or surgery
Video calls were made with the telemedicine group.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine group | Active comparator | The study participants were evaluated through telemedicine visits at specific intervals after the baseline visit, with the following schedule:
* 1st visit: At day 10 post-baseline
* 2nd visit: At the end of the 1st month
* 3rd visit: At the end of the 3rd month
These visits were conducted by the principal investigator using telemedicine. Additional telemedicine visits were arranged for patients in the telemedicine group as required. Receives: Procedure: Telemedicine |
| Control group | No intervention | The visits for the control group, due to being conducted face-to-face in the outpatient clinic, were carried out by the routine attending physician at the clinic, who was not aware of the study. As suggested in the discharge recommendations during the baseline visit (0th visit) for the control group, they were advised to return for a follow-up visit on the 10th day and to schedule these follow-up appointments through the hospital's system. No intervention was made to facilitate the scheduling of these appointments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler adherence
At the end of 3 months, inhaler adherence was compared. A 6-item Inhaler Adherence Scale (IAS) was used to evaluate inhaler treatment compliance. If the patient answered "yes" to even one of the items, they were deemed non-compliant.
The questions:
''During the last 3 months;
- have you at times been careless about using your inhaler or nebulizer?,
- have you ever forgotten to use your inhaler or nebulizer?
- have you ever stopped using your inhaler because you felt better?
- have you ever stopped using your inhaler or nebulizer because you felt worse?
- have you ever used your inhaler or nebulizer less than the doctor prescribed because you felt better?
- have you ever used your inhaler or nebulizer more than the doctor prescribed because you felt you were having an attack?''.
Measured: 3 months
Secondary outcomes (1)
COPD Assesment Test (CAT) score
The aim of the investigator's study is to test whether telemedicine is a safe and effective method for the follow-up of patients with advanced-stage COPD after exacerbations, to see if there is a difference in treatment adherence after 3 months of observation compared to face-to-face healthcare services, and to evaluate if there is a difference in CAT scores.
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2023
- Study completion15 Oct 2023
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 TelehealthStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a prospective, randomized controlled, method clinical research study. Patients who were hospitalized with COPD exacerbation in the last year were included in the study and were divided into 2 groups.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Sena Doğan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477328
- Sponsor's protocol ID
- GAZISOLMAZ01
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dogan ZS, Kokturk N. Evaluation of patients diagnosed with chronic obstructive pulmonary disease in terms of treatment compliance and quality of life after follow-up with telemedicine: a randomized controlled trial. BMC Pulm Med. 2025 Aug 26;25(1):408. doi: 10.1186/s12890-025-03854-z.
PubMed 40859183
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Compliance of Patients Diagnosed With Chronic Obstructive Pulmonary Disease And Their Quality of Life After Follow-up: Evaluation Via Telemedicine
- ClinicalTrials.gov ID
- NCT06477328
- Acronym / sponsor ID
- GAZISOLMAZ01
- Conditions
- Telehealth, Copd
- Keywords
- telemedicine, copd, inhaler adherence, inhaler technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 27 Jun 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 Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare provided face-to-face.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a prospective, randomized controlled, method clinical research study. Patients who were hospitalized with COPD exacerbation in the last year were included in the study and were divided into 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | Active comparator | Procedure: TelemedicineThe study participants were evaluated through telemedicine visits at specific intervals after the baseline visit, with the following schedule: * 1st visit: At day 10 post-baseline * 2nd visit: At the end of the 1st month * 3rd visit: At the end of the 3rd month These visits were conducted by the principal investigator using telemedicine. Additional telemedicine visits were arranged for patients in the telemedicine group as required. |
| Control group | No intervention | –The visits for the control group, due to being conducted face-to-face in the outpatient clinic, were carried out by the routine attending physician at the clinic, who was not aware of the study. As suggested in the discharge recommendations during the baseline visit (0th visit) for the control group, they were advised to return for a follow-up visit on the 10th day and to schedule these follow-up appointments through the hospital's system. No intervention was made to facilitate the scheduling of these appointments. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were diagnosed with COPD according to Global Initiative for Obstructive Lung Disease (GOLD)
- GOLD spirometric grade 3-4
- At least one hospital admission in the past year
- Acceptable score on the Mini-Mental State Examination
- Residing in Ankara
Key exclusion criteria (16 listed)
- Patients diagnosed with asthma
- Patients with lung cancer
- Patients with combined pulmonary fibrosis and emphysema
- Patients with active infections such as pneumonia or COVID-19
- Patients being followed for COPD without spirometry
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 |
|---|---|---|
| TelemedicineVideo calls were made with the telemedicine group. | Procedure or surgery | Telemedicine group |
Primary outcome
Inhaler adherence
Time frame: 3 months
At the end of 3 months, inhaler adherence was compared. A 6-item Inhaler Adherence Scale (IAS) was used to evaluate inhaler treatment compliance. If the patient answered "yes" to even one of the items, they were deemed non-compliant. The questions: ''During the last 3 months; * have you at times been careless about using your inhaler or nebulizer?, * have you ever forgotten to use your inhaler or nebulizer? * have you ever stopped using your inhaler because you felt better? * have you ever stopped using your inhaler or nebulizer because you felt worse? * have you ever used your inhaler or nebulizer less than the doctor prescribed because you felt better? * have you ever used your inhaler or nebulizer more than the doctor prescribed because you felt you were having an attack?''.
1 secondary outcome
COPD Assesment Test (CAT) score
Time frame: 3 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 27 Jun 2024.
- Derived from this study: PubMed 40859183Dogan ZS, Kokturk N. Evaluation of patients diagnosed with chronic obstructive pulmonary disease in terms of treatment compliance and quality of life after follow-up with telemedicine: a randomized controlled trial. BMC Pulm Med. 2025 Aug 26;25(1):408. doi: 10.1186/s12890-025-03854-z.
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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.
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 Telemedicine in people with Telehealth and Copd, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 9 inclusion and 16 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 27 Jun 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 Turkey (Türkiye). 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?
Inhaler adherence (time frame: 3 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 NCT06477328, 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 27 Jun 2024.