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At Home Spirometry and Video Module Education for COPD Patients (BREATHES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03834350
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : April 12, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 7, 2019
Last Update Posted Date April 12, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Virtual Education Module Adherence [ Time Frame: 30 days ]
    A Yes/No measure of whether participant completed the virtual education module at least once before the 30 day follow-up visit.
  • Rate of SpiroPD device usage for At-Home COPD Self-Management [ Time Frame: 30 days ]
    A measure of whether or not the patient used the SpiroPD device to perform lung function test and keep track of medications.
  • Inhaler Technique [ Time Frame: 30 days ]
    A measure of inhaler misuse (≤10/12 steps correct) from prior to the virtual education module to the 30 day follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03834350 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Change in Self-Efficacy for Inhalers: 5 point Likert scale [ Time Frame: 30 days ]
    A self-reported self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure, from prior to virtual education module to after virtual education module
  • Change in Symptom Burden [ Time Frame: 30 days ]
    Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and the COPD Severity Tool (the possible COPD severity score range is 0 to 35, with higher scores reflecting more severe disease). The measure will be from prior the BREATHES program to after the completion of the 30 day BREATHES program.
  • Change in Quality of Life: The Airway Questionnaire (AQ-20) [ Time Frame: 30 days ]
    Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 - high scores indicate poor quality of life.
  • Use of Acute Care Services [ Time Frame: 30 day ]
    Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE At Home Spirometry and Video Module Education for COPD Patients
Official Title  ICMJE BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management
Brief Summary

The central hypothesis is that patients hospitalized for COPD who subsequently complete the at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will retain increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays substantially by 30 days post-discharge. To test this hypothesis, this study proposes the following specific aims:

Aim 1: Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for ongoing inhaler skill training.

Hypothesis: Participants who complete both in-hospital and at-home V-TTG will have a significantly increased likelihood of demonstrating effective respiratory inhaler technique within 30 days after hospital discharge compared to in-hospital technique

Aim 2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for COPD medication adherence support.

Hypothesis: Participants' use of SpiroPD (PMD Healthcare) will significantly improve their COPD medication adherence.

Detailed Description

Chronic obstructive pulmonary disease (COPD) results in nearly 750,000 hospitalizations annually and is the third leading cause of 30-day hospital readmissions in the United States.Improving the quality of care for hospitalized COPD patients has recently become a national priority through the Centers for Medicare and Medicaid Services' Hospital Readmissions Reduction Program. A key element of improving care quality is translating existing evidence into improved practice. Extensive evidence exists to support the efficacy of inhaled medications to control and reduce COPD symptoms and to improve patient outcomes. However, the real-world effectiveness of these medications is often limited due both to poor inhaler technique and to insufficient adherence to treatment plans. Most interventions for hospitalized patients with COPD focus on medication reconciliation, treatment optimization, and inhaler technique education prior to being discharged home. However, after discharge home, patients quickly lose inhaler technique skills, have difficulty adhering to complex regimens, and lack tools to aid adherence, such as lung function response to their treatment regimen. Interventions to reinforce skills and support adherence are needed across care transitions to reduce the risk of deleterious health outcomes.

Simple and feasible at-home interventions to provide skills training and adherence support are needed. This novel idea is to pair at-home inhaler skill training with at-home spirometry measurements to comprehensively support both medication skill and adherence. The investigator proposes testing a novel at-home self-management support program called "BREATHES" (Bringing Respiratory Education for improved Adherence and Technique Home through E-interventions for Self-management) Program. BREATHES will include two main components: first, self-directed inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention the investigator developed and tested during a K23 grant and, second, a handheld lung function device to provide physiologic feedback and capture medication adherence called SpiroPD. TTG is a patient-centered strategy that uses cycles of assessment and demonstration tailored to patients' self-management needs; the investigator's research shows in-person TTG is effective for teaching inhaler technique and reduces acute care utilization. Virtual-TTG delivers the key features of TTG using virtual patient-directed lessons through novel adaptive technology that provides tailored self-assessment and training. The investigator's studies demonstrate participants' willingness to use V-TTG at-home for post-discharge booster education and show that V-TTG is effective and may be non-inferior to in-person TTG in significantly reducing inhaler misuse among hospitalized patients. However, it remains unknown whether at-home V-TTG sessions will maintain self-management skills over the longer term and how direct physiologic lung monitoring support can impact medication adherence. The proposed studies will determine whether combining at-home skill training with objective measurements of lung function and adherence monitoring through the BREATHES Program improves self-management skills and medication adherence in the first 30 days after hospitalization for COPD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE COPD
Intervention  ICMJE Other: BREATHES Program
Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.A small device will be attached to track real-time medication use.
Study Arms  ICMJE At-Home Breathes Program
Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.
Intervention: Other: BREATHES Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 years and older
  2. Physician-diagnosed COPD (prior to or during hospitalization)
  3. Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.)
  4. Discharged with a rescue and/or controller MDI, metered dose inhaler.

Exclusion Criteria:

  1. Currently in an intensive care unit
  2. Physician declines to provide consent
  3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Akel 773-834-4489
Contact: Sebastian Otero 773-834-1985
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03834350
Other Study ID Numbers  ICMJE IRB18-1210
R03HL144883 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Valerie G Press, MD, MPH Associate Professor
PRS Account University of Chicago
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP