- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323190
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitively impaired (including sedation)
- Intubated
- Non-English-speaking
- Receiving palliative or hospice service
- Enrolled in any other educational research s
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inpatient COPD patient
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gained knowledge
Time Frame: 1 year
|
Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary rehab enrollment
Time Frame: 1 year
|
Number of subjects that have enrolled in pulmonary rehab.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jones 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.
- 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.
- 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.
- Cramm 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.
- Zwar 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.
- Maples 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.
- Messenger 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.
- Cooney 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.
- Taylor 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.
- Adis Medical Writers. (2013). Managing coexistent asthma and chronic obstructive pulmonary disease in older populations is challenging. Drugs & Therapy Perspectives, 29, 141-144.
- Duley 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.
- Lawlor 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15121607-IRB04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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