Improvement in COPD Elderly Patients Health: Study Protocol

Medical University of Lodz

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Intervention 2; Other: Intervention 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04301505

2016/21/B/NZ7/02052

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,520 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,520 participants in 3 patient groups

control

No Intervention group

Description:

Usual care.

Intervention 1

Other group

Description:

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

Treatment:

Other: Intervention 1

Intervention 2

Other group

Description:

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

Treatment:

Other: Intervention 2