An Educational Intervention to Improve Disease Management... | NCT03323190

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

NCT03323190

Sponsor

Rush University Medical Center

Status

Withdrawn

Last Update Posted

Dec 10, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Patient Education
Inpatients

Interventions

Inpatient COPD education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn due to low feasibility.

Expanded Access Info

Start Date

Aug 30, 2016Actual

Primary Completion Date

Aug 30, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Feb 10, 2017

First Submission Date that Met QC Criteria

Oct 23, 2017

First Posted Date

Oct 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2020

Last Update Posted Date

Dec 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Behavioral: Inpatient COPD education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inpatient COPD education	Behavioral		Inpatient COPD patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gained knowledge	Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).	1 year

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary rehab enrollment	Number of subjects that have enrolled in pulmonary rehab.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23290705	Background	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.
23641152	Background

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease