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Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499470
Recruitment Status : Unknown
Verified July 2019 by Begum Ergan, Dokuz Eylul University.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
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
T.C. ORDU ÜNİVERSİTESİ
Hacettepe University
Turkish Directorate General of Public Health
Istanbul University Cerrahpaşa Faculty
Diskapi Yildirim Beyazit Education and Research Hospital
Information provided by (Responsible Party):
Begum Ergan, Dokuz Eylul University

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Noninvasive Ventilation Long Term Oxygen Therapy Chronic Respiratory Failure Other: Protocol for structured discharge and follow-up Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention

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
 Other: Protocol for structured discharge and follow-up
No Intervention: Control
Control patients will receive usual care


Outcome Measures
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Primary Outcome Measures :
  1. Readmission rate [ Time Frame: 90days ]
    The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge


Secondary Outcome Measures :
  1. Time to first exacerbation [ Time Frame: 90 days ]
    Time to first exacerbation after discharge

  2. Rate of exacerbation [ Time Frame: 90 days ]
    Total COPD exacerbation rate within 90 days after discharge

  3. Rate of hospitalization [ Time Frame: 90 days ]
    Total hospitalization number due to COPD within 90 days after discharge

  4. Compliance to treatment [ Time Frame: 90 days ]
    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.

  5. Long term survival [ Time Frame: One year ]
    One year survival after discharge


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. PaO2 ≤ 55 mmHg or SaO2 ≤ 88% under room air
  2. PaO2 value of 55-59 mmHg or SaO2 ≤ 89% and cor pulmonale with hematocrit >55 or p pulmonale in ECG or congestive heart failure.

Eligibility for NIV:

  1. PaCO2≥55 mmHg or
  2. 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

Exclusion Criteria:

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.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499470


Locations
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Turkey
Dokuz Eylul University
Izmir, Narlıdere, Turkey, 35340
Cukurova University
Adana, Turkey
Gazi University
Ankara, Turkey
Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
Ankara, Turkey
Uludag University
Bursa, Turkey
Duzce University
Düzce, Turkey
Ataturk University
Erzurum, Turkey
Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
Istanbul, Turkey
Ege University
Izmir, Turkey
Celal Bayar University
Manisa, Turkey
Sponsors and Collaborators
Dokuz Eylul University
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
T.C. ORDU ÜNİVERSİTESİ
Hacettepe University
Turkish Directorate General of Public Health
Istanbul University Cerrahpaşa Faculty
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Study Director: BEGUM ERGAN, MD Dokuz Eylul University
Study Director: TUGBA GOKTALAY, MD Celal Bayar University
Principal Investigator: PINAR ERGUN, MD Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
Principal Investigator: ALEV GURGUN, MD Ege University
Principal Investigator: METIN AKGUN, MD Ataturk University
Principal Investigator: NURDAN KOKTURK, MD Gazi University
Principal Investigator: EZGI OZYILMAZ, MD Cukurova University
Principal Investigator: ASLI DILEKTASLI, MD Uludag University
Principal Investigator: BIRSEN OCAKLI, MD Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
Principal Investigator: ONER BALBAY, MD Duzce University
More Information
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Responsible Party: Begum Ergan, Instructor, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03499470    
Other Study ID Numbers: 20.478.486.359
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Begum Ergan, Dokuz Eylul University:
copd
exacerbation
structured discharge
readmission
chronic respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases