Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
home telemedicine, home spirometer
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.
Interventions
DEVICEGo 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.
Sponsors
Midmark Corporation
Monitored Therapeutics, Inc
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study.
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Home Telemedicine Device |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 3 months
Population: Data were reported for all participants who completed both initial and final CAT score over the entire 3-month study duration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Telemedicine Device | Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score | 57 percentage of participants |
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
Time frame: 3 months
Population: Data were reported for all participants who completed all 3 device component measurements over the entire 3-month study duration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Telemedicine Device | Percentage of Participants With Home Device Measurement Collection Adherence | 63 percentage of participants |
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.
Time frame: 3 months
Population: Data were reported for all participants who completed the final survey at the 3-month visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home Telemedicine Device | Median Communication Frequency Survey Score at 3 Months | 3 score on a scale |
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.
Time frame: 3 months
Population: Data were reported for all participants who completed the final survey at the 3-month visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home Telemedicine Device | Median Number of Ideal Daily Questions Score at 3 Months | 5 score on a scale |
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.
Time frame: 3 months
Population: Data were reported for all participants who completed the final survey at the 3-month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | COPD Prevented Spirometry Use | 36 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Spirometer Ease of Use | 46 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Spirometer Helpful in Symptom Management | 46 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Spirometer Helpful for Identifying Health Problems | 46 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Spirometer Helpful for Doctor | 55 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Spirometer Helpful for Safety & Security | 73 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Willingness to Continue Spirometer Use | 45 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Likelihood to Recommend Spirometer | 82 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Appeal of Animated Respiratory Therapist Character | 64 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Tablet Ease of Use | 82 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Tablet Helpful in Symptom Management | 73 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Likelihood to Recommend Tablet | 44 percentage of participants |
| Home Telemedicine Device | Percentage of Participants With Individual Survey Domains Score of 4 or Higher | Appeal of Tablet | 82 percentage of participants |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Home Telemedicine Device | Rate of Self-reported COPD Exacerbations | 0.14 exacerbations per 30 days |