COPD ExacerbationNCT03499470
Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV
A study testing Protocol for structured discharge and follow-up in people with COPD Exacerbation and Noninvasive Ventilation, run by Dokuz Eylul University at 10 sites in Turkey (Türkiye).
Trial summary
Readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the most vulnerable group because of the need for… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy
- What is being tested?
- Protocol for structured discharge and follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 7 Nov 2016to 31 Aug 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients who developed chronic respiratory failure and are eligible for long-term oxygen therapy (LTOT) or noninvasive ventilation (NIV) according to Turkish National Social Security regulations
- Definitions:
- COPD: The diagnosis of COPD is made according to GOLD criteria Chronic respiratory failure: PaO2>60mmHg at room air and/or PaCO2> 45
- Eligibility for LTOT:
- PaO2 ≤ 55 mmHg or SaO2 ≤ 88% under room air
- PaO2 value of 55-59 mmHg or SaO2 ≤ 89% and cor pulmonale with hematocrit >55 or p pulmonale in ECG or congestive heart failure.
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- Eligibility for NIV:
- PaCO2≥55 mmHg or
- PaCO2 50 to 54 mmHg and nocturnal desaturation ≤ %88 for 5 minutes under 2lt/min nasal O2 therapy 3. PaCO2 50 to 54 mmHg and >2 exacerbations within the last year
Who cannot join
- 1. Patients receiving LTOT or NIV for a different cause 2. Patients who do not give consent 3. Patients who are unable to be followed up regularly due to reasons such as living far from study center, lack of family support, unwillingness or inability to contact regularly.
- -
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Turkey (Türkiye)10 sites
Cukurova University
Adana
Gazi University
Ankara
Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
Ankara
Uludag University
Bursa
Duzce University
Düzce
Ataturk University
Erzurum
Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
Istanbul
Dokuz Eylul University
Izmir, Narlıdere, 35340
Ege University
Izmir
Celal Bayar University
Manisa
About this study
Official title: The Effectiveness of Structured Discharge and Follow-up Protocol on Readmission Rate in COPD Patients Receiving LTOT and NIV: A Multicenter Randomized Trial
Readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the most vulnerable group because of the need for comprehensive care. However, because of lack of health care support systems in Turkey, many advanced COPD patients are hospitalized due to preventable problems such as insufficient knowledge about the therapies, nonadherence to therapy and technical issues related to LTOT/NIV equipment. The aim of this multicenter randomized trial is to find out whether a structured discharge and follow-up protocol reduce the rate of unplanned, COPD-related hospital readmissions over 90 days in patients receiving LTOT or NIV.
Read the detailed description
The study is planned with Turkish Thoracic Society and Global Alliance Against Respiratory Disease-Turkey partnership and being carried out 10 centers throughout Turkey. COPD patients who are prescribed long-term oxygen therapy for hypoxemic respiratory failure and/or noninvasive ventilation for hypercapnic respiratory failure will be included in the study and will be randomized to either intervention or control arm. The intervention mainly consists of not only education about the disease and medications but also the education of the equipment and how to use it to have the best benefit. Control arm patients will receive usual care, which consists of basic education of the patient about the therapies. The primary outcome of the study is readmission in 90 days.
- Conditions
- COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy, Chronic Respiratory Failure
- Being tested
- Protocol for structured discharge and follow-up
- Keywords
- copd, exacerbation, structured discharge, readmission, chronic respiratory failure
- 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.
Protocol for structured discharge and follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The intervention mainly consists of a developed protocol for education about the disease and medications AND an education of the equipment and how to use it to have the best benefit.
Actions in structured discharge and follow up protocol:
1. Patient education for disease severity and medications
2. Education of family/relatives about medications and types of equipment
3. Detailed education for LTOT and/or NIV (how to use, duration of use, solutions for possible common problems)
4. Preparation of home environment for patients needs
5. Regular telephone visits on day 7 and day 14 after discharge and telephone visits in emergency situations and early referral to the hospital when needed
6. Outpatient control for the first month Receives: Other: Protocol for structured discharge and follow-up |
| Control | No intervention | Control patients will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate
The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge
Measured: 90days
Secondary outcomes (5)
Time to first exacerbation
Time to first exacerbation after discharge
Measured: 90 days
Rate of exacerbation
Total COPD exacerbation rate within 90 days after discharge
Measured: 90 days
Rate of hospitalization
Total hospitalization number due to COPD within 90 days after discharge
Measured: 90 days
Compliance to treatment
Compliance to LTOT and NIV therapies will be assessed by duration of use (number of hours per day and number of nights per week) within 90 days after discharge.
Measured: 90 days
Long term survival
One year survival after discharge
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start7 Nov 2016
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Manisa Celal Bayar University, Ege University, Gazi University, Duzce University, Cukurova University, Ataturk University, Uludag University, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Ordu University, Hacettepe University, Turkish Directorate General of Public Health, Istanbul University - Cerrahpasa, Diskapi Yildirim Beyazit Education and Research Hospital
- Responsible party
- Principal investigator, Begum Ergan, Dokuz Eylul University
- Investigators
- BEGUM ERGAN, MD, Study director, Dokuz Eylul UniversityTUGBA GOKTALAY, MD, Study director, Manisa Celal Bayar UniversityPINAR ERGUN, MD, Principal investigator, Health Sciences University Ataturk Chest Diseases and Chest Surgery HospitalALEV GURGUN, MD, Principal investigator, Ege UniversityMETIN AKGUN, MD, Principal investigator, Ataturk UniversityNURDAN KOKTURK, MD, Principal investigator, Gazi UniversityEZGI OZYILMAZ, MD, Principal investigator, Cukurova UniversityASLI DILEKTASLI, MD, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499470
- Sponsor's protocol ID
- 20.478.486.359
- Status last verified
- Jul 2019
- First submitted
- 2 Apr 2018
- Last updated
- 18 Jul 2019
- 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Structured Discharge and Follow-up Protocol on Readmission Rate in COPD Patients Receiving LTOT and NIV: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT03499470
- Acronym / sponsor ID
- 20.478.486.359
- Conditions
- COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy, Chronic Respiratory Failure
- Keywords
- copd, exacerbation, structured discharge, readmission, chronic respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Manisa Celal Bayar University, Ege University, Gazi University, Duzce University, Cukurova University, Ataturk University, Uludag University, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Ordu University, Hacettepe University, Turkish Directorate General of Public Health, Istanbul University - Cerrahpasa, Diskapi Yildirim Beyazit Education and Research Hospital
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 17 Apr 2018 (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.
Readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the most vulnerable group because of the need for comprehensive care. However, because of lack of health care support systems in Turkey, many advanced COPD patients are hospitalized due to preventable problems such as insufficient knowledge about the therapies, nonadherence to therapy and technical issues related to LTOT/NIV equipment. The aim of this multicenter randomized trial is to find out whether a structured discharge and follow-up protocol reduce the rate of unplanned, COPD-related hospital readmissions over 90 days in patients receiving LTOT or NIV.
Detailed description
The study is planned with Turkish Thoracic Society and Global Alliance Against Respiratory Disease-Turkey partnership and being carried out 10 centers throughout Turkey. COPD patients who are prescribed long-term oxygen therapy for hypoxemic respiratory failure and/or noninvasive ventilation for hypercapnic respiratory failure will be included in the study and will be randomized to either intervention or control arm. The intervention mainly consists of not only education about the disease and medications but also the education of the equipment and how to use it to have the best benefit. Control arm patients will receive usual care, which consists of basic education of the patient about the therapies. The primary outcome of the study is readmission in 90 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Protocol for structured discharge and follow-upThe intervention mainly consists of a developed protocol for education about the disease and medications AND an education of the equipment and how to use it to have the best benefit. Actions in structured discharge and follow up protocol: 1. Patient education for disease severity and medications 2. Education of family/relatives about medications and types of equipment 3. Detailed education for LTOT and/or NIV (how to use, duration of use, solutions for possible common problems) 4. Preparation of home environment for patients needs 5. Regular telephone visits on day 7 and day 14 after discharge and telephone visits in emergency situations and early referral to the hospital when needed 6. Outpatient control for the first month |
| Control | No intervention | –Control patients will receive usual care |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- COPD patients who developed chronic respiratory failure and are eligible for long-term oxygen therapy (LTOT) or noninvasive ventilation (NIV) according to Turkish National Social Security regulations
- COPD: The diagnosis of COPD is made according to GOLD criteria Chronic respiratory failure: PaO2>60mmHg at room air and/or PaCO2> 45
- PaO2 ≤ 55 mmHg or SaO2 ≤ 88% under room air
- PaO2 value of 55-59 mmHg or SaO2 ≤ 89% and cor pulmonale with hematocrit >55 or p pulmonale in ECG or congestive heart failure.
- PaCO2≥55 mmHg or
Key exclusion criteria (2 listed)
- 1. Patients receiving LTOT or NIV for a different cause 2. Patients who do not give consent 3. Patients who are unable to be followed up regularly due to reasons such as living far from study center, lack of family support, unwillingness or inability to contact regularly.
- -
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 |
|---|---|---|
| Protocol for structured discharge and follow-up | Other | Intervention |
Primary outcome
Readmission rate
Time frame: 90days
The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge
5 secondary outcomes
Time to first exacerbation
Time frame: 90 days
Rate of exacerbation
Time frame: 90 days
Rate of hospitalization
Time frame: 90 days
Compliance to treatment
Time frame: 90 days
Long term survival
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
BEGUM ERGAN, MD study director
Dokuz Eylul University
TUGBA GOKTALAY, MD study director
Manisa Celal Bayar University
PINAR ERGUN, MD principal investigator
Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol for structured discharge and follow-up in people with COPD Exacerbation and Noninvasive Ventilation, run by Dokuz Eylul University at 10 sites 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 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
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?
Readmission rate (time frame: 90days). 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 18 Jul 2019.