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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Intervention / Treatment
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* Other: Introductory Disease Education


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care: This group will receive usual care from their physician without any special focus on education. At the end of the study period, patients that were assigned to the control group will receive the booklet at home and be offered two education sessions by phone or in-person if the patient is willing to return to the hospital. | |
| Active Comparator: Education Intervention<br>Introductory disease education: This group will attend two one-on-one education sessions. The educational content will be standardized and a checklist will be used to ensure that all topics are addressed. The sessions will focus on enhancing self-efficacy in areas that are thought to be important to individuals who recently had an AECOPD. | Other: Introductory Disease Education<br>* This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.<br>* Other names: COPD Education Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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. | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AECOPD, COPD, education