Chronic Obstructive Pulmonary Disease With (Acute) ExacerbationNCT02321215
Effectiveness and Feasibility of Delivering an Education Program to Patients With an Acute Exacerbation of COPD
A study testing Introductory Disease Education in people with Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation, run by West Park Healthcare Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
- What is being tested?
- Introductory Disease Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- medically confirmed diagnosis of AECOPD (alone or combined with other conditions)
- capable of understanding the study information and giving informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Introductory Disease Education
- Keywords
- AECOPD, COPD, education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introductory Disease EducationOther
Also called COPD Education Program
This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Introductory Disease Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in disease specific knowledge
Bristol COPD Knowledge Questionnaire (BCKQ)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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? (#)
Measured: 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)
Measured: This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease With (Acute) ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Janaudis Ferreira, West Park Healthcare Centre
- Investigators
- Roger Goldstein, MD, Study chair, West Park Healthcare CentreSamantha Harrison, PhD, Study chair, West Park Healthcare CentreDavid Fishbein, MD, Study chair, Humber River HospitalSean Carr, MD, Study chair, Humber River HospitalAndrea Gershon, MD, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321215
- Sponsor's protocol ID
- CRHP_EducationAECOPD2014
- Status last verified
- May 2016
- First submitted
- 3 Dec 2014
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29879395
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02321215
- Acronym / sponsor ID
- CRHP_EducationAECOPD2014
- Keywords
- AECOPD, COPD, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Introductory Disease EducationIntroductory 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- medically confirmed diagnosis of AECOPD (alone or combined with other conditions)
- capable of understanding the study information and giving informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introductory Disease EducationAlso: COPD Education ProgramThis intervention will consist of two one-on-one education sessions, each lasting 30 minutes. | Other | Education Intervention |
Primary outcome
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)
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)
4 secondary outcomes
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).
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).
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Derived from this study: PubMed 29879395Janaudis-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.
Related trials for Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
Recruiting
Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD
Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of COPD
RecruitingObservational study
Interoception and Symptom Perception in Acute COPD Exacerbation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Interoceptive Awareness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Goldstein, MD study chair
West Park Healthcare Centre
Samantha Harrison, PhD study chair
West Park Healthcare Centre
David Fishbein, MD study chair
Humber River Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introductory Disease Education in people with Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.