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OpenTrials
Completed

NCT Number: NCT04301505

Improvement in COPD Elderly Patients Health: Study Protocol

Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. We have developed an educational program based on a checklist to assist general practitioners in managing COPD patients. The results of this trial based on electronic health records from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist, will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care and patient's quality of life.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lodz

Lodz, 90-153, Poland

About this study

This study is the three-arm cluster controlled randomized trial (CRT) with the patients nested within practices. The effectiveness of Checklist in reduction of COPD exacerbations health outcomes in COPD patients after 2 interventions will be evaluated and compared to that of usual care. The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10).
  • Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed.

Exclusion criteria

None

Treatment and study plan

Intervention 1

Other

Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.

Intervention 2

Other

The same checklist will be delivered at the beginning of the study and repeated after 6 months.

Primary outcomes

  1. The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.

    Time frame: 12 months

    Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year.

Secondary outcomes

  1. The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention.

    Time frame: 12 months

    Variables from BIG DATA databases, electronic health records (EHR) associated with checklist will be used to assess patients' health outcomes.

    The effect of the educational intervention will be evaluated using logistic 2-level regression analysis.

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Collaborators

  • National Science Centre, Poland

Registry information

Official study title

Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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