Effectiveness and Feasibility of Delivering an Education Program to Patients With an Acute Exacerbation of COPD

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321215
• Other study ID #: CRHP_EducationAECOPD2014
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: May 20, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Introductory Disease Education
This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.

Locations

Country	Name	City	State
Canada	Humber River Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in disease specific knowledge	Bristol COPD Knowledge Questionnaire (BCKQ)	This primary outcome measure will be collected prior to randomization and approximately four weeks after admission	No
Primary	Change from baseline in information needs	Lung Information Needs Questionnaire (LINQ)	This primary outcome measure will be collected prior to randomization and approximately four weeks after admission	No
Secondary	Feasibility measure: number of eligible patients		This outcome variable will be noted within 1-2 days of hospital admission with an AECOPD (when determining patient eligibility, before randomization).	No
Secondary	Feasibility measure: ease of recruiting patients	Questions: (1) Is it easy to locate the patient in their room? (Yes/No) (2) How many times did the RA try to find the patient in the room before successfully finding them there? (#) (3) Does the patient have enough time to meet with the RA? (Yes/No)	This outcome variable will be noted within 1-2 days of hospitalization, while the patient is being recruited (before randomization).	No
Secondary	Feasibility measure: compliance to the sessions	Questions: (1) Is the participant able to complete the half-hour session? (Yes/No) (2) How many times was the education session interrupted for any reason? (#)	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.	No
Secondary	Feasibility measure: follow-up rates	Proportion of subjects that complete the follow up stage (questionnaire responses)	This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).	No