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

NCT02321215 | Completed

• 1 other identifier: CRHP_EducationAECOPD2014
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Keywords

AECOPD; COPD; education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  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

  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

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

Study Arms (2)

Control

NO INTERVENTION

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.

Education Intervention

ACTIVE COMPARATOR

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

Interventions

Introductory Disease Education OTHER

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

Also known as: COPD Education Program

Education Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

Humber River Hospital

Toronto, Ontario, M3N 1N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 29879395 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 22, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

CA (1)