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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT04369885
• Collaborator: Midmark Corporation (Other), Monitored Therapeutics, Inc (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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.
• Primary Purpose: Supportive Care
• Official Title: Assessing Adherence to Home Telemedicine in Individuals With COPD
• Actual Study Start Date: Jul 1, 2020
• Actual Primary Completion Date: May 24, 2021
• Actual Study Completion Date: May 24, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Home Device Measurement Collection Adherence [3 months]

   Percentage of participants achieving >50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months

2. Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score [3 months]

   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

1. Percentage of Participants With Individual Survey Domains Score of 4 or Higher [3 months]

   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.

2. Median Communication Frequency Survey Score at 3 Months [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. Median Number of Ideal Daily Questions Score at 3 Months [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."

4. Rate of Self-reported COPD Exacerbations [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meadowmont Marsico Lung Research Center	Chapel Hill	North Carolina	United States	27517

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Michael B Drummond, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2020
• Informed Consent Form - Jun 18, 2020

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04369885
• Other Study ID Numbers: 20-0107
• First Posted: Apr 30, 2020
• Last Update Posted: Nov 3, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by University of North Carolina, Chapel Hill: home telemedicine; home spirometer
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
COMPLETED	10
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.6 (6.7)
Sex: Female, Male (Count of Participants)
Female	9 75%
Male	3 25%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	12 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	12 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were reported for all participants who completed all 3 device component measurements over the entire 3-month study duration.

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	8
Number (95% Confidence Interval) [percentage of participants]	63 525%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were reported for all participants who completed both initial and final CAT score over the entire 3-month study duration.

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	7
Number (95% Confidence Interval) [percentage of participants]	57 475%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were reported for all participants who completed the final survey at the 3-month visit.

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	11
COPD Prevented Spirometry Use	36 300%
Spirometer Ease of Use	46 383.3%
Spirometer Helpful in Symptom Management	46 383.3%
Spirometer Helpful for Identifying Health Problems	46 383.3%
Spirometer Helpful for Doctor	55 458.3%
Spirometer Helpful for Safety & Security	73 608.3%
Willingness to Continue Spirometer Use	45 375%
Likelihood to Recommend Spirometer	82 683.3%
Appeal of Animated Respiratory Therapist Character	64 533.3%
Tablet Ease of Use	82 683.3%
Tablet Helpful in Symptom Management	73 608.3%
Likelihood to Recommend Tablet	44 366.7%
Appeal of Tablet	82 683.3%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were reported for all participants who completed the final survey at the 3-month visit.

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	11
Median (Inter-Quartile Range) [score on a scale]	3

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were reported for all participants who completed the final survey at the 3-month visit.

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	11
Median (Inter-Quartile Range) [score on a scale]	5

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
Measure Participants	12
Mean (95% Confidence Interval) [exacerbations per 30 days]	0.14

Adverse Events

Time Frame	From signing of informed consent throughout duration of study, a total of approximately 3 months.
Arm/Group Title	Home Telemedicine Device
Arm/Group Description	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.
All Cause Mortality
	Home Telemedicine Device
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Home Telemedicine Device
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Home Telemedicine Device
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.