Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)

NCT01426581 | Completed Results DMC

• 1 other identifier: 11-0248
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education. Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction. The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Asthma; Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Disease, Chronic Obstructive; Lung Disease, Obstructive; Self-management; Health Literacy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge

  To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.

  1 month

Secondary Outcomes (4)

• Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events

  1 month

• Number of Participants With Self-Efficacy

  1 month

• Symptom Control

  1 month

• Number of Participants With Acute Care Events 30 Days Post Discharge

  1 month

Study Arms (2)

Educational Intervention A

EXPERIMENTAL

Intervention: Teach to Goal

Behavioral: Teach-To-Goal

Educational Intervention B:

EXPERIMENTAL

Brief Intervention

Behavioral: Brief Intervention

Interventions

Teach-To-Goal BEHAVIORAL

Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)

Educational Intervention A

Brief Intervention BEHAVIORAL

Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)

Educational Intervention B:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Admitting diagnosis of asthma or COPD
• Physician- diagnosed asthma, asthma/COPD, or COPD. We will enroll patients even if the primary reason for admission is not asthma or COPD (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible)
• Patient will be discharged home on a Metered Dose Inhaler (MDI; e.g., albuterol)

You may not qualify if:

• Currently in an intensive care unit
• Physician declines to provide consent
• Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
• Previous participant in this study

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Press VG, Arora VM, Trela KC, Adhikari R, Zadravecz FJ, Liao C, Naureckas E, White SR, Meltzer DO, Krishnan JA. Effectiveness of Interventions to Teach Metered-Dose and Diskus Inhaler Techniques. A Randomized Trial. Ann Am Thorac Soc. 2016 Jun;13(6):816-24. doi: 10.1513/AnnalsATS.201509-603OC.

  PMID: 26998961 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Valerie G. Press, MD, MPH
• Organization: University of Chicago

vpress@medicine.bsd.uchicago.edu

73-702-5170

Study Officials

• Valerie G Press, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 19, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Locations

US (1)