Improvement in COPD Elderly Patients Health: Study Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention 1

COPD management checklist will be delivered at the beginning of the study.

Group Type OTHER

Intervention 1

Intervention Type 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

COPD management checklist will be delivered at the beginning of the study and repeated after 6 months.

Group Type OTHER

Intervention 2

Intervention Type OTHER

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

Interventions

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Intervention 1

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 Type OTHER

Intervention 2

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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