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

NCT ID: NCT02321215

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Introductory Disease Education

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Introductory Disease Education

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

COPD Education Program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West Park Healthcare Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tania Janaudis Ferreira

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roger Goldstein, MD

Role: STUDY_CHAIR

West Park Healthcare Centre

Samantha Harrison, PhD

Role: STUDY_CHAIR

West Park Healthcare Centre

David Fishbein, MD

Role: STUDY_CHAIR

Humber River Hospital

Sean Carr, MD

Role: STUDY_CHAIR

Humber River Hospital

Andrea Gershon, MD

Role: STUDY_CHAIR

Sunnybrook Health Sciences Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Humber River Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29879395 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRHP_EducationAECOPD2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of COPD Co-Pilot
NCT02944591 UNKNOWN
Evaluating the EAPOC-COPD System
NCT06852339 NOT_YET_RECRUITING NA
Evaluation of COPD Co-Pilot
NCT03018847 UNKNOWN
An Evaluation of Web Based Pulmonary Rehabilitation
NCT02404831 COMPLETED PHASE1/PHASE2