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

NCT04369885 | Completed Results FDA Device

• 1 other identifier: 20-0107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

home telemedicine; home spirometer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Percentage of Participants With Individual Survey Domains Score of 4 or Higher

  3 months

• Median Communication Frequency Survey Score at 3 Months

  3 months

• Median Number of Ideal Daily Questions Score at 3 Months

  3 months

• Rate of Self-reported COPD Exacerbations

  3 months

Study Arms (1)

Home Telemedicine Device

EXPERIMENTAL

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

Interventions

Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter DEVICE

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.

Home Telemedicine Device

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Midmark Corporation: collaborator
• Monitored Therapeutics, Inc: collaborator

Study Sites (1)

Meadowmont Marsico Lung Research Center

Chapel Hill, North Carolina, 27517, 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: Michael B Drummond, MD
• Organization: University of North Carolina at Chapel Hill

brad_drummond@med.unc.edu

919-966-7054

Study Officials

• Michael B Drummond, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 quality of life (QoL) Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a University of North Carolina (UNC) clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics Incorporated CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: July 1, 2020
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: November 3, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)