At Home Spirometry and Video Module Education for COPD Patients

NCT03834350 | Completed Results DMC FDA Device

• 2 other identifiers: IRB18-1210R03HL144883
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• Virtual Education Module Adherence

  Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.

  30 days

• Rate of SpiroPD Device Usage for At-Home COPD Self-Management

  Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.

  30 days

• Inhaler Technique

  Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up

  Baseline; Baseline post-education; 30-day post-discharge

Secondary Outcomes (4)

• Change in Self-Efficacy for Inhalers: 5 Point Likert Scale

  Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)

• Change in Symptom Burden

  Baseline; 30 days post-discharge

• Change in Quality of Life: The Airway Questionnaire (AQ-20)

  Baseline; 30 days post-discharge

• Use of Acute Care Services

  30 day

Study Arms (1)

At-Home Breathes Program

OTHER

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.

Other: BREATHES Program; Device: BREATHES SpiroPD or Propeller Health

Interventions

BREATHES Program OTHER

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.

At-Home Breathes Program

BREATHES SpiroPD or Propeller Health DEVICE

At the time of their initial study visit, study participants may 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.

At-Home Breathes Program

Eligibility Criteria

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

You may qualify if:

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

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

Sponsors & Collaborators

• University of Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Valerie Press
• Organization: University of Chicago

vpress@bsd.uchicago.edu

773-702-5170

Study Officials

• Valerie G Press, MD, MPH

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 7, 2019
• Study Start: April 11, 2019
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: July 22, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-07

Locations

US (1)