NCT02611531

Brief Summary

The purpose of this study is to evaluate the 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

November 18, 2015

Last Update Submit

May 23, 2018

Conditions

Chronic Obstructive Pulmonary DiseaseAsthma

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants with metered dose inhaler (MDI) misuse post VME vs. TTG education. This will provide data on the short-term effectiveness of the interventions.

    Assess patient's inhaler technique using Inhaler checklists by the trained assessor.

    Up to 30 days

Secondary Outcomes (5)

  • Symptom burden

    Up to 30 days

  • Quality of Life (QOL)

    up to 30 days

  • self-efficacy of inhaler technique

    up to 30 days

  • Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)

    Up to 30 days

  • Lung function

    Up to 30 days

Study Arms (2)

Video Module Education (VME)

EXPERIMENTAL

The RE will provide participants with a tablet device and will demonstrate how to access VME and complete the pre/post e-learning assessments. The RE will provide technical support but will neither participate directly in the education nor help with the self-assessments. The participants will first complete the pre-assessment e-learning tool on the tablet. They will then watch the video instruction that will provide a complete demonstration with verbal instructions on correct inhaler technique. Next the participants will complete the post-assessment e-learning tool. Based on participants' performance, they will be directed to further tailored video-instruction. The cycle of self-assessment and video instruction will continue until sufficient mastery has been achieved.

Behavioral: Video Module Education (VME)

Teach-To-Goal (TTG)

ACTIVE COMPARATOR

Participants assigned to the TTG condition will be provided with an intensive, iterative education and evaluation strategy that consists of the following steps.

Behavioral: Teach-To-Goal (TTG)

Interventions

Video Module Education (VME)BEHAVIORAL

Participants will complete inhaler education on a tablet device

Video Module Education (VME)
Teach-To-Goal (TTG)BEHAVIORAL

Participants will complete intensive in-person inhaler education

Teach-To-Goal (TTG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Admission to the inpatient medical service and surgical service
  • Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible).

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Press VG, Arora VM, Kelly CA, Carey KA, White SR, Wan W. Effectiveness of Virtual vs In-Person Inhaler Education for Hospitalized Patients With Obstructive Lung Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1918205. doi: 10.1001/jamanetworkopen.2019.18205.

    PMID: 31899529DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Valerie G Press, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

US(1)