NCT04301505

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 18, 2020

Last Update Submit

February 21, 2023

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD)elderlyexacerbation of COPDprevalencechecklistrandomized controlled trialelectronic health records

Outcome Measures

Primary Outcomes (1)

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

    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.

    12 months

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.

    12 months

Study Arms (3)

control

NO INTERVENTION

Usual care.

Intervention 1

OTHER

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

Other: Intervention 1

Intervention 2

OTHER

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

Other: Intervention 2

Interventions

Intervention 1OTHER

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 1
Intervention 2OTHER

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

Intervention 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz

Lodz, 90-153, Poland

Location

Related Publications (1)

  • Kowalczyk A, Zakowska I, Andrzejewska E, Kosiek K, Godycki-Cwirko M. A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records. Trials. 2021 Feb 25;22(1):161. doi: 10.1186/s13063-021-05103-0.

    PMID: 33632282DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maciek Godycki-Cwirko, Prof.

    Centre for Family and Community Medicine, Medical Univeristy of Lodz, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 10, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2021

Study Completion

March 31, 2021

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

PL(1)