Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

Assessing Adherence to Home Telemedicine in Individuals With COPD

This is a single-site feasibility pilot study to determine if patients with COPD with an increased risk of exacerbation will use an in-home COPD telemonitoring system for three months that collects lung measures, pulse oximetry, and medication compliance.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter

Detailed Description

This is a single-site, prospective, open label trial evaluating home telemonitoring for patients with COPD and a history of increased exacerbation risk. The purpose of this study is to determine whether automated home monitoring of medication compliance and biometric parameters [forced expiratory capacity in one second (FEV1), forced vital capacity (FVC), peak inspiratory flow rate (PIFR), inspiratory capacity (IC), pulse oximetry, and symptoms] is acceptable to patients, can improve adherence, and may improve clinical outcomes and reduce exacerbations and avoidable 30-day readmissions. Slow spirometry will be performed Sundays, Mondays, Wednesdays, Fridays and Saturdays. Forced spirometry will be performed Tuesdays and Thursdays.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Meadowmont Marsico Lung Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female patients
• 40 to 80 years of age
• English speaking
• Spirometry confirmed COPD (post-bronchodilator FEV1/FVC<0.70) and post-bronchodilator FEV1% predicted <80% at screening visit. (Target 50% of recruitment with post-bronchodilator FEV1<50% predicted (severe obstruction))

• Increased COPD exacerbation risk defined as either of the following in the prior 12 months:

  • One hospitalization for COPD exacerbation
  • Two outpatient COPD exacerbations requiring treatment with steroids and/or antibiotics
• Signed informed consent

Exclusion Criteria:

• Unable to perform spirometry on their own following training.
• Planned discharge to a nursing home or other extended care facility
• Co-morbid conditions likely to result in non-preventable readmissions (e.g., terminal malignancy, cirrhosis or end-stage liver disease, chronic wound infections, etc.)
• Uncontrolled or untreated medical conditions that would predispose the patient to recurrent COPD exacerbations (i.e., bronchiectasis)
• Patient refusal to or inability to comply with monitoring requirements, for any reason including but not limited to dementia, a history of dementia, or other significant mental impairment
• Patients enrolled in any other clinical trials or therapeutic studies of drugs, devices, or biologics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home Telemedicine Device; This arm will receive the intervention of the home telemedicine device for three months.

Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter; All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Home Device Measurement Collection Adherence	Percentage of participants achieving >50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months	3 months
Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score	Percentage of participants achieving ≥2 point decrease in CAT from baseline to three months. The CAT is a short, self-completed, 8-item questionnaire, each item is rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating severe condition.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Individual Survey Domains Score of 4 or Higher	The percentage of participants with score of 4 or higher on individual survey domains. A satisfaction survey (investigator-developed, 13 questions, each question is graded on a scale of 1-5, 1 being not at all and 5 being extremely) will be used to measure home spirometry and table ease and usefulness.	3 months
Median Communication Frequency Survey Score at 3 Months	The median score on a survey question focused on frequency of communication between device and participant. A survey question (investigator-developed, single question) included a scale of 1-5, 1 being "way too much" and 5 being "I wanted a lot more".	3 months
Median Number of Ideal Daily Questions Score at 3 Months	The median score on a survey question focused on the ideal number of questions asked by the device per day. A survey question (investigator-developed, single question) asking participants to indicate how many questions per day was "right" with choices ranging from "1" to "5 or more."	3 months
Rate of Self-reported COPD Exacerbations	The 30-day COPD exacerbation rate, defined as the mean number of events/30 days of follow-up (using three months of follow-up data). COPD exacerbation events are defined as self-reported COPD exacerbations requiring treatment with antibiotics or steroids.	3 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Midmark Corporation; Monitored Therapeutics, Inc
• Investigators: Principal Investigator: Michael B Drummond, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): May 24, 2021
• Study Completion (Actual): May 24, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: home telemedicine; home spirometer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 20-0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No