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| Name | Class |
|---|---|
| Midmark Corporation | INDUSTRY |
| Monitored Therapeutics, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Telemedicine Device | Experimental | This arm will receive the intervention of the home telemedicine device for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Drummond, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meadowmont Marsico Lung Research Center | Chapel Hill | North Carolina | 27517 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Data were reported for all participants who completed all 3 device component measurements over the entire 3-month study duration. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
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From signing of informed consent throughout duration of study, a total of approximately 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael B Drummond, MD | University of North Carolina at Chapel Hill | 919-966-7054 | brad_drummond@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2020 | Sep 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2020 | Sep 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
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This is an open-label study.
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|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| Primary | 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. | Data were reported for all participants who completed both initial and final CAT score over the entire 3-month study duration. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
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|
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| Secondary | 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. | Data were reported for all participants who completed the final survey at the 3-month visit. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
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|
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| Secondary | 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". | Data were reported for all participants who completed the final survey at the 3-month visit. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
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|
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| Secondary | 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." | Data were reported for all participants who completed the final survey at the 3-month visit. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
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|
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | exacerbations per 30 days | 3 months |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Spirometer Helpful for Identifying Health Problems |
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| Spirometer Helpful for Doctor |
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| Spirometer Helpful for Safety & Security |
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| Willingness to Continue Spirometer Use |
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| Likelihood to Recommend Spirometer |
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| Appeal of Animated Respiratory Therapist Character |
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| Tablet Ease of Use |
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| Tablet Helpful in Symptom Management |
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| Likelihood to Recommend Tablet |
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| Appeal of Tablet |
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