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NCT03323190 Clinical Trial

An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03323190
Other study ID # 15121607-IRB04
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 30, 2016
Est. completion date August 30, 2017

Study information
Verified date December 2020
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Inpatient COPD education

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

Adis Medical Writers. (2013). Managing coexistent asthma and chronic obstructive pulmonary disease in older populations is challenging. Drugs & Therapy Perspectives, 29, 141-144.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Aug 10. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Gained knowledge Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). 1 year
Secondary Pulmonary rehab enrollment Number of subjects that have enrolled in pulmonary rehab. 1 year
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