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Completed

NCT Number: NCT02321215

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humber River Hospital

Toronto, Ontario, M3N 1N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Introductory Disease Education

Other

This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.

Other names: COPD Education Program

Primary outcomes

  1. Change from baseline in disease specific knowledge

    Time frame: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission

    Bristol COPD Knowledge Questionnaire (BCKQ)

  2. Change from baseline in information needs

    Time frame: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission

    Lung Information Needs Questionnaire (LINQ)

Secondary outcomes

  1. Feasibility measure: number of eligible patients

    Time frame: This outcome variable will be noted within 1-2 days of hospital admission with an AECOPD (when determining patient eligibility, before randomization).

  2. Feasibility measure: ease of recruiting patients

    Time frame: This outcome variable will be noted within 1-2 days of hospitalization, while the patient is being recruited (before randomization).

    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)

  3. Feasibility measure: compliance to the sessions

    Time frame: 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.

    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? (#)

  4. Feasibility measure: follow-up rates

    Time frame: This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).

    Proportion of subjects that complete the follow up stage (questionnaire responses)

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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