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

May 20, 2016 updated by: Tania Janaudis Ferreira, West Park Healthcare Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3N 1N1
        • Humber River Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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
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
This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.
Other Names:
  • COPD Education Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
This primary outcome measure will be collected prior to randomization and approximately four weeks after admission
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)
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
Time Frame: This outcome variable will be noted within 1-2 days of hospital admission with an AECOPD (when determining patient eligibility, before randomization).
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
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)
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
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? (#)
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
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)
This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Park Healthcare Centre

Investigators

  • Study Chair: Roger Goldstein, MD, West Park Healthcare Centre
  • Study Chair: Samantha Harrison, PhD, West Park Healthcare Centre
  • Study Chair: David Fishbein, MD, Humber River Hospital
  • Study Chair: Sean Carr, MD, Humber River Hospital
  • Study Chair: Andrea Gershon, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRHP_EducationAECOPD2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Clinical Trials on Introductory Disease Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe