COPD PatientsNCT06128902
The Effect of Home-Based Monitoring, Exercise Training
A study testing tele health in people with COPD Patients, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD); From time to time, significant involvement in dusts or gases and abnormal disease outbreaks are observed, which are observed throughout life in the period when the cause has just emerged, interruption of air flow with disruptions in air flow, shortness of breath, increase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Patients
- What is being tested?
- tele health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the research,
- Diagnosed with COPD,
- Able to use a smartphone,
- Oriented and cooperative,
- Does not have a psychiatric disorder that impairs verbal communication, such as schizophrenia or dementia,
- Having no communication problems.
Who cannot join
- Having alcohol or drug addiction,
- Those with physical disabilities,
- Illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Home-Based Monitoring, Counseling and Exercise Training Applied to Individuals With Chronic Obstructive Pulmonary Disease by Tele-Counselling Method on Repeated Hospitalization and Quality of Life of Individuals
Chronic obstructive pulmonary disease (COPD); From time to time, significant involvement in dusts or gases and abnormal disease outbreaks are observed, which are observed throughout life in the period when the cause has just emerged, interruption of air flow with disruptions in air flow, shortness of breath, increase in the amount of secretion. Directly or indirectly, very high costs are incurred in COPD care and promotion. While mild stages are treated without directed hospitalization, hospitalizations become more frequent as the disease progresses, and the duration of hospitalization in each acute attack increases compared to the next attack. Acute exacerbations of COPD negatively affect the rates of rehospitalization and emergency service admissions, and the living conditions of this condition, whose long-term cause of death and morbidity has not yet been revealed, do not lead to negative aspects. Exercise programs applied in chronic diseases should include stopping their illnesses, increasing sleep during the disease, stopping inflammatory acuteness, and in addition to treatment, the rest of the patients should be normal. It has been stated that it is more effective than home-based hospital system applications in pulmonary regulation, and it has been taken positively from applications compatible with the basic field, as everywhere in the world. In this direction, the effect of home-based monitoring, education and exercise training applied to individuals with COPD via tele-consultancy method on repeated hospitalization and quality of life is revealed.
- Conditions
- COPD Patients
- Being tested
- tele health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele healthOther
Also called education
home based exercise and telenursing
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | COPD patients Receives: Other: tele health |
| Control group | No intervention | COPD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
repeated hospitalizations
after randomization and 12 weeks later
Measured: They will be questioned about the number of times they were admitted to hospital due to COPD during 12 weeks.
Secondary outcomes (1)
Quality of life that COPD patients
after randomization and 12 weeks later
Measured: Their quality of life will be evaluated with the SF-36 quality of life (Short Form) immediately after randomization and 12 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 May 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife DURGUN, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128902
- Sponsor's protocol ID
- Tele-nursing
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-Based Monitoring, Counseling and Exercise Training Applied to Individuals With Chronic Obstructive Pulmonary Disease by Tele-Counselling Method on Repeated Hospitalization and Quality of Life of Individuals
- ClinicalTrials.gov ID
- NCT06128902
- Acronym / sponsor ID
- Tele-nursing
- Conditions
- COPD Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 13 Nov 2023 (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); From time to time, significant involvement in dusts or gases and abnormal disease outbreaks are observed, which are observed throughout life in the period when the cause has just emerged, interruption of air flow with disruptions in air flow, shortness of breath, increase in the amount of secretion. Directly or indirectly, very high costs are incurred in COPD care and promotion. While mild stages are treated without directed hospitalization, hospitalizations become more frequent as the disease progresses, and the duration of hospitalization in each acute attack increases compared to the next attack. Acute exacerbations of COPD negatively affect the rates of rehospitalization and emergency service admissions, and the living conditions of this condition, whose long-term cause of death and morbidity has not yet been revealed, do not lead to negative aspects. Exercise programs applied in chronic diseases should include stopping their illnesses, increasing sleep during the disease, stopping inflammatory acuteness, and in addition to treatment, the rest of the patients should be normal. It has been stated that it is more effective than home-based hospital system applications in pulmonary regulation, and it has been taken positively from applications compatible with the basic field, as everywhere in the world. In this direction, the effect of home-based monitoring, education and exercise training applied to individuals with COPD via tele-consultancy method on repeated hospitalization and quality of life is revealed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized-control
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: tele healthCOPD patients |
| Control group | No intervention | –COPD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agreeing to participate in the research,
- Diagnosed with COPD,
- Able to use a smartphone,
- Oriented and cooperative,
- Does not have a psychiatric disorder that impairs verbal communication, such as schizophrenia or dementia,
Key exclusion criteria (3 listed)
- Having alcohol or drug addiction,
- Those with physical disabilities,
- Illiterate.
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 |
|---|---|---|
| tele healthAlso: educationhome based exercise and telenursing | Other | intervention group |
Primary outcome
repeated hospitalizations
Time frame: They will be questioned about the number of times they were admitted to hospital due to COPD during 12 weeks.
after randomization and 12 weeks later
1 secondary outcome
Quality of life that COPD patients
Time frame: Their quality of life will be evaluated with the SF-36 quality of life (Short Form) immediately after randomization and 12 weeks later.
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 13 Nov 2023.
- 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.
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 tele health in people with COPD Patients, run by Ordu University 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 6 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 13 Nov 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 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?
repeated hospitalizations (time frame: They will be questioned about the number of times they were admitted to hospital due to COPD during 12 weeks.). 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 13 Nov 2023.