Chronic Obstructive Pulmonary DiseaseNCT03323190
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
A study testing Inpatient COPD education in people with Chronic Obstructive Pulmonary Disease and Patient Education, run by Rush University Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Patient Education, Inpatients
- What is being tested?
- Inpatient COPD education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2016to 30 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of COPD
- Spirometry confirmation of COPD either from chart or bedside spirometry i. FEV1(forced expiatory volume in 1 second)/FVC (forced vital capacity) <70% ii. FEV1 < 80% predicted
- Willingness to participate
- English-speaking
- Working phone
Who cannot join
- Cognitively impaired (including sedation)
- Intubated
- Non-English-speaking
- Receiving palliative or hospice service
- Enrolled in any other educational research s
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.
Read the detailed description
A prospective cohort study utilizing a pre-test/post-test design will be used to test a COPD education intervention on a convenience sample of 30 patients with a diagnosis of COPD. Study participants will complete the Chronic Obstructive Pulmonary Disease questionnaire (COPD-Q) to assess their COPD knowledge. Next, a respiratory therapist will provide the first scripted COPD education session. The patient will complete the COPD-Q 24 hours and 30 days post-discharge. Demographic data, smoking status, pack-years, COPD spirometry grade, COPD symptom and exacerbation grade, previous hospital admissions, support system for managing COPD, attendance at previous formal education for COPD, current and home medications, pulmonary function test (PFT) results, vaccinations, and level of education data will be collected. Data related to patient recruitment will also be collected. Means and standard deviation will be reported for interval data. Total frequency and percentages will be reported for nominal data, and median and 25th and 75th percentile will be reported for COPD severity. Repeated measures ANOVA (p< 0.05) will be used to evaluate if an inpatient COPD self-management intervention can increase the patient's knowledge of COPD after 24 hours and again at 30 days after the initial education session.
This study is expected to show that an inpatient education of COPD can increase the patient's COPD knowledge prior to discharge and that it will be retained for at least one month post-discharge.
- Being tested
- Inpatient 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.
Inpatient COPD educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Inpatient COPD patient | Experimental | All COPD patients meeting the inclusion criteria of this study will be exposed to inpatient COPD education and tested at a later date to determine if knowledge on COPD was gained. Receives: Behavioral: Inpatient COPD education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gained knowledge
Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
Measured: 1 year
Secondary outcomes (1)
Pulmonary rehab enrollment
Number of subjects that have enrolled in pulmonary rehab.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start30 Aug 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Withdrawn due to low feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323190
- Sponsor's protocol ID
- 15121607-IRB04
- Status last verified
- Dec 2020
- First submitted
- 10 Feb 2017
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sayiner A, Alzaabi A, Obeidat NM, Nejjari C, Beji M, Uzaslan E, Nafti S, Khan JA, Tageldin MA, Idrees M, Rashid N, El Hasnaoui A; BREATHE Study Group. Attitudes and beliefs about COPD: data from the BREATHE study. Respir Med. 2012 Dec;106 Suppl 2:S60-74. doi: 10.1016/S0954-6111(12)70015-X.
PubMed 23290705Cramm JM, Nieboer AP. The relationship between self-management abilities, quality of chronic care delivery, and wellbeing among patients with chronic obstructive pulmonary disease in The Netherlands. Int J Chron Obstruct Pulmon Dis. 2013;8:209-14. doi: 10.2147/COPD.S42667. Epub 2013 Apr 26.
PubMed 23641152Zwar NA, Hermiz O, Comino E, Middleton S, Vagholkar S, Xuan W, Wilson SF, Marks GB. Care of patients with a diagnosis of chronic obstructive pulmonary disease: a cluster randomised controlled trial. Med J Aust. 2012 Oct 1;197(7):394-8. doi: 10.5694/mja12.10813.
PubMed 23025736Maples P, Franks A, Ray S, Stevens AB, Wallace LS. Development and validation of a low-literacy Chronic Obstructive Pulmonary Disease knowledge Questionnaire (COPD-Q). Patient Educ Couns. 2010 Oct;81(1):19-22. doi: 10.1016/j.pec.2009.11.020. Epub 2009 Dec 30.
PubMed 20044232Messenger RW. Reducing chronic obstructive pulmonary disease readmissions: the role of the durable medical equipment provider. Prof Case Manag. 2012 May-Jun;17(3):109-14; quiz 115-6. doi: 10.1097/NCM.0b013e31823ba2b8.
PubMed 22488339Cooney A, Mee L, Casey D, Murphy K, Kirwan C, Burke E, Conway Y, Healy D, Mooney B, Murphy J; PRINCE Team. Life with chronic obstructive pulmonary disease: striving for 'controlled co-existence'. J Clin Nurs. 2013 Apr;22(7-8):986-95. doi: 10.1111/j.1365-2702.2012.04285.x. Epub 2013 Jan 2.
PubMed 23279604Taylor SJ, Candy B, Bryar RM, Ramsay J, Vrijhoef HJ, Esmond G, Wedzicha JA, Griffiths CJ. Effectiveness of innovations in nurse led chronic disease management for patients with chronic obstructive pulmonary disease: systematic review of evidence. BMJ. 2005 Sep 3;331(7515):485. doi: 10.1136/bmj.38512.664167.8F. Epub 2005 Aug 10.
PubMed 16093253Adis Medical Writers. (2013). Managing coexistent asthma and chronic obstructive pulmonary disease in older populations is challenging. Drugs & Therapy Perspectives, 29, 141-144.
Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
PubMed 23258783Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809Duley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, Chrolavicius S, Li T, Ounpuu S, Perez AC, Sleight P, Svard R, Temple R, Tsouderous Y, Yunis C, Yusuf S. Specific barriers to the conduct of randomized trials. Clin Trials. 2008;5(1):40-8. doi: 10.1177/1740774507087704.
PubMed 18283079Lawlor M, Kealy S, Agnew M, Korn B, Quinn J, Cassidy C, Silke B, O'Connell F, O'Donnell R. Early discharge care with ongoing follow-up support may reduce hospital readmissions in COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:55-60. Epub 2009 Apr 15.
PubMed 19436695
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
- ClinicalTrials.gov ID
- NCT03323190
- Acronym / sponsor ID
- 15121607-IRB04
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to low feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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 objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.
Detailed description
A prospective cohort study utilizing a pre-test/post-test design will be used to test a COPD education intervention on a convenience sample of 30 patients with a diagnosis of COPD. Study participants will complete the Chronic Obstructive Pulmonary Disease questionnaire (COPD-Q) to assess their COPD knowledge. Next, a respiratory therapist will provide the first scripted COPD education session. The patient will complete the COPD-Q 24 hours and 30 days post-discharge. Demographic data, smoking status, pack-years, COPD spirometry grade, COPD symptom and exacerbation grade, previous hospital admissions, support system for managing COPD, attendance at previous formal education for COPD, current and home medications, pulmonary function test (PFT) results, vaccinations, and level of education data will be collected. Data related to patient recruitment will also be collected. Means and standard deviation will be reported for interval data. Total frequency and percentages will be reported for nominal data, and median and 25th and 75th percentile will be reported for COPD severity. Repeated measures ANOVA (p< 0.05) will be used to evaluate if an inpatient COPD self-management intervention can increase the patient's knowledge of COPD after 24 hours and again at 30 days after the initial education session.
This study is expected to show that an inpatient education of COPD can increase the patient's COPD knowledge prior to discharge and that it will be retained for at least one month post-discharge.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient COPD patient | Experimental | Behavioral: Inpatient COPD educationAll COPD patients meeting the inclusion criteria of this study will be exposed to inpatient COPD education and tested at a later date to determine if knowledge on COPD was gained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of COPD
- Spirometry confirmation of COPD either from chart or bedside spirometry i. FEV1(forced expiatory volume in 1 second)/FVC (forced vital capacity) <70% ii. FEV1 < 80% predicted
- Willingness to participate
- English-speaking
- Working phone
Key exclusion criteria (5 listed)
- Cognitively impaired (including sedation)
- Intubated
- Non-English-speaking
- Receiving palliative or hospice service
- Enrolled in any other educational research s
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 |
|---|---|---|
| Inpatient COPD education | Behavioural | Inpatient COPD patient |
Primary outcome
Gained knowledge
Time frame: 1 year
Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
1 secondary outcome
Pulmonary rehab enrollment
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 23290705Sayiner A, Alzaabi A, Obeidat NM, Nejjari C, Beji M, Uzaslan E, Nafti S, Khan JA, Tageldin MA, Idrees M, Rashid N, El Hasnaoui A; BREATHE Study Group. Attitudes and beliefs about COPD: data from the BREATHE study. Respir Med. 2012 Dec;106 Suppl 2:S60-74. doi: 10.1016/S0954-6111(12)70015-X.
- Background: PubMed 23641152Cramm JM, Nieboer AP. The relationship between self-management abilities, quality of chronic care delivery, and wellbeing among patients with chronic obstructive pulmonary disease in The Netherlands. Int J Chron Obstruct Pulmon Dis. 2013;8:209-14. doi: 10.2147/COPD.S42667. Epub 2013 Apr 26.
- Background: PubMed 23025736Zwar NA, Hermiz O, Comino E, Middleton S, Vagholkar S, Xuan W, Wilson SF, Marks GB. Care of patients with a diagnosis of chronic obstructive pulmonary disease: a cluster randomised controlled trial. Med J Aust. 2012 Oct 1;197(7):394-8. doi: 10.5694/mja12.10813.
- Background: PubMed 20044232Maples P, Franks A, Ray S, Stevens AB, Wallace LS. Development and validation of a low-literacy Chronic Obstructive Pulmonary Disease knowledge Questionnaire (COPD-Q). Patient Educ Couns. 2010 Oct;81(1):19-22. doi: 10.1016/j.pec.2009.11.020. Epub 2009 Dec 30.
- Background: PubMed 22488339Messenger RW. Reducing chronic obstructive pulmonary disease readmissions: the role of the durable medical equipment provider. Prof Case Manag. 2012 May-Jun;17(3):109-14; quiz 115-6. doi: 10.1097/NCM.0b013e31823ba2b8.
- Background: PubMed 23279604Cooney A, Mee L, Casey D, Murphy K, Kirwan C, Burke E, Conway Y, Healy D, Mooney B, Murphy J; PRINCE Team. Life with chronic obstructive pulmonary disease: striving for 'controlled co-existence'. J Clin Nurs. 2013 Apr;22(7-8):986-95. doi: 10.1111/j.1365-2702.2012.04285.x. Epub 2013 Jan 2.
- Background: PubMed 16093253Taylor SJ, Candy B, Bryar RM, Ramsay J, Vrijhoef HJ, Esmond G, Wedzicha JA, Griffiths CJ. Effectiveness of innovations in nurse led chronic disease management for patients with chronic obstructive pulmonary disease: systematic review of evidence. BMJ. 2005 Sep 3;331(7515):485. doi: 10.1136/bmj.38512.664167.8F. Epub 2005 Aug 10.
- BackgroundAdis Medical Writers. (2013). Managing coexistent asthma and chronic obstructive pulmonary disease in older populations is challenging. Drugs & Therapy Perspectives, 29, 141-144.
- Background: PubMed 23258783Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
- Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Background: PubMed 18283079Duley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, Chrolavicius S, Li T, Ounpuu S, Perez AC, Sleight P, Svard R, Temple R, Tsouderous Y, Yunis C, Yusuf S. Specific barriers to the conduct of randomized trials. Clin Trials. 2008;5(1):40-8. doi: 10.1177/1740774507087704.
- Background: PubMed 19436695Lawlor M, Kealy S, Agnew M, Korn B, Quinn J, Cassidy C, Silke B, O'Connell F, O'Donnell R. Early discharge care with ongoing follow-up support may reduce hospital readmissions in COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:55-60. Epub 2009 Apr 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient COPD education in people with Chronic Obstructive Pulmonary Disease and Patient Education, run by Rush University Medical Center at 1 site in United States.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Dec 2020. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Gained knowledge (time frame: 1 year). 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 NCT03323190, which also lists 12 linked publications.
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 10 Dec 2020.