Back to resultsAssessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring home telemedicine, home spirometer
Eligibility Criteria
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
Sites / Locations
- Meadowmont Marsico Lung Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home Telemedicine Device
Arm Description
This arm will receive the intervention of the home telemedicine device for three months.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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".
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."
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.
Full Information
NCT ID
NCT04369885
First Posted
April 27, 2020
Last Updated
October 29, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Midmark Corporation, Monitored Therapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04369885
Brief Title
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Assessing Adherence to Home Telemedicine in Individuals With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Midmark Corporation, Monitored Therapeutics, Inc
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
home telemedicine, home spirometer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
This is an open-label study.
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Telemedicine Device
Arm Type
Experimental
Arm Description
This arm will receive the intervention of the home telemedicine device for three months.
Intervention Type
Device
Intervention Name(s)
Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Home Device Measurement Collection Adherence
Description
Percentage of participants achieving >50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months
Time Frame
3 months
Title
Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Description
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.
Time Frame
3 months
Title
Median Communication Frequency Survey Score at 3 Months
Description
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".
Time Frame
3 months
Title
Median Number of Ideal Daily Questions Score at 3 Months
Description
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."
Time Frame
3 months
Title
Rate of Self-reported COPD Exacerbations
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Drummond, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meadowmont Marsico Lung Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
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