Clinical trial NCT02321215: Effectiveness and Feasibility of Delivering an Education Program to Patients With an Acute Exacerbation of COPD
Official title: Effectiveness and Feasibility of Delivering an Introductory Education Program to Patients Admitted to Hospital With an Acute Exacerbation of COPD - a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Keywords: AECOPD
COPD
education
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if it is effective and feasible to provide a chronic obstructive pulmonary disease (COPD) education program to patients admitted with an acute exacerbation of COPD.

Detailed description: Following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) evidence strongly suggests that all patients should be discharged with an action plan, consisting of identified patient responsibilities for their ongoing care and advice on recognizing and seeking help in the event of future acute exacerbations. Despite these recommendations, structured chronic obstructive pulmonary disease (COPD) specific education is rarely offered within acute hospital settings and, in addition, research in this area is limited. This study aims to determine the effectiveness and feasibility of an introductory education program delivered during and shortly after an AECOPD hospitalization.

Eligibility criteria: Inclusion Criteria:

* medically confirmed diagnosis of AECOPD (alone or combined with other conditions)
* capable of understanding the study information and giving informed consent

Exclusion Criteria:

* admitted due to lung diseases other than COPD
* received COPD education in the previous 6 months (in primary care, acute or rehabilitation hospitals)
* presence of diagnosis of dementia or incapacity to learn due to cognitive issues
* have medical, cognitive or language limitations to communicating in written or spoken English
* have participated or been asked to participate in the trial before
* in the intensive care unit

Primary outcomes:
measure: Change from baseline in disease specific knowledge
timeFrame: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission
measure: Change from baseline in information needs
timeFrame: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission
Secondary outcomes:
measure: Feasibility measure: number of eligible patients
timeFrame: This outcome variable will be noted within 1-2 days of hospital admission with an AECOPD (when determining patient eligibility, before randomization).
measure: Feasibility measure: ease of recruiting patients
timeFrame: This outcome variable will be noted within 1-2 days of hospitalization, while the patient is being recruited (before randomization).
measure: Feasibility measure: compliance to the sessions
timeFrame: This outcome measure will be noted after each education session. The education sessions will take place between 3-15 days after hospital admission for an AECOPD. Two education sessions will be delivered to every patient enrolled in the intervention arm.
measure: Feasibility measure: follow-up rates
timeFrame: This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein, MD
role: STUDY_CHAIR
affiliation: West Park Healthcare Centre
name: Samantha Harrison, PhD
role: STUDY_CHAIR
affiliation: Humber River Hospital
name: David Fishbein, MD
role: STUDY_CHAIR
affiliation: Humber River Hospital
name: Sean Carr, MD
role: STUDY_CHAIR
affiliation: Sunnybrook Health Sciences Centre
name: Andrea Gershon, MD
role: STUDY_CHAIR
References:
citation: Janaudis-Ferreira T, Carr SJ, Harrison SL, Gershon AS, Milner SC, Carr S, Fishbein D, Goldstein R. Can Patients With COPD Assimilate Disease-Specific Information During an Acute Exacerbation?: Results of a Pilot Randomized Controlled Trial. Chest. 2018 Sep;154(3):588-596. doi: 10.1016/j.chest.2018.05.028. Epub 2018 Jun 4.