Trial Outcomes & Findings for Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT04369885)
NCT ID: NCT04369885
Last Updated: 2021-11-03
Results Overview
Percentage of participants achieving \>50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
3 months
Results posted on
2021-11-03
Participant Flow
Participant milestones
| Measure |
Home Telemedicine Device
This arm will receive the intervention of the home telemedicine device for three months.
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Home Telemedicine Device
n=12 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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Age, Continuous
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63.6 years
STANDARD_DEVIATION 6.7 • n=39 Participants
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Sex: Female, Male
Female
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9 Participants
n=39 Participants
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Sex: Female, Male
Male
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3 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
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Race (NIH/OMB)
White
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12 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Region of Enrollment
United States
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12 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: 3 monthsPopulation: Data were reported for all participants who completed all 3 device component measurements over the entire 3-month study duration.
Percentage of participants achieving \>50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months
Outcome measures
| Measure |
Home Telemedicine Device
n=8 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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|---|---|
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Percentage of Participants With Home Device Measurement Collection Adherence
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63 percentage of participants
Interval 25.0 to 91.0
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PRIMARY outcome
Timeframe: 3 monthsPopulation: Data were reported for all participants who completed both initial and final CAT score over the entire 3-month study duration.
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.
Outcome measures
| Measure |
Home Telemedicine Device
n=7 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score
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57 percentage of participants
Interval 18.0 to 90.0
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were reported for all participants who completed the final survey at the 3-month visit.
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.
Outcome measures
| Measure |
Home Telemedicine Device
n=11 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
COPD Prevented Spirometry Use
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36 percentage of participants
Interval 11.0 to 69.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Spirometer Ease of Use
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46 percentage of participants
Interval 17.0 to 77.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Spirometer Helpful in Symptom Management
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46 percentage of participants
Interval 17.0 to 77.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Spirometer Helpful for Identifying Health Problems
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46 percentage of participants
Interval 17.0 to 77.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Spirometer Helpful for Doctor
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55 percentage of participants
Interval 23.0 to 83.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Spirometer Helpful for Safety & Security
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73 percentage of participants
Interval 39.0 to 94.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Willingness to Continue Spirometer Use
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45 percentage of participants
Interval 17.0 to 77.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Likelihood to Recommend Spirometer
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82 percentage of participants
Interval 48.0 to 98.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Appeal of Animated Respiratory Therapist Character
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64 percentage of participants
Interval 31.0 to 89.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Tablet Ease of Use
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82 percentage of participants
Interval 48.0 to 98.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Tablet Helpful in Symptom Management
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73 percentage of participants
Interval 39.0 to 94.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Likelihood to Recommend Tablet
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44 percentage of participants
Interval 14.0 to 79.0
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Percentage of Participants With Individual Survey Domains Score of 4 or Higher
Appeal of Tablet
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82 percentage of participants
Interval 49.0 to 98.0
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were reported for all participants who completed the final survey at the 3-month visit.
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".
Outcome measures
| Measure |
Home Telemedicine Device
n=11 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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|---|---|
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Median Communication Frequency Survey Score at 3 Months
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3 score on a scale
Interval 3.0 to 3.0
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were reported for all participants who completed the final survey at the 3-month visit.
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."
Outcome measures
| Measure |
Home Telemedicine Device
n=11 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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Median Number of Ideal Daily Questions Score at 3 Months
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5 score on a scale
Interval 4.0 to 5.0
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SECONDARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Home Telemedicine Device
n=12 Participants
This arm will receive the intervention of the home telemedicine device for three months.
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.
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Rate of Self-reported COPD Exacerbations
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0.14 exacerbations per 30 days
Interval 0.0 to 0.28
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Adverse Events
Home Telemedicine Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael B Drummond, MD
University of North Carolina at Chapel Hill
Phone: 919-966-7054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place