Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Assessing Adherence to Home Telemedicine in Individuals With COPD
NCT number | NCT04369885 |
Other study ID # | 20-0107 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | May 24, 2021 |
Verified date | September 2021 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 24, 2021 |
Est. primary completion date | May 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Meadowmont Marsico Lung Research Center | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Midmark Corporation, Monitored Therapeutics, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 3 months | |
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. | 3 months | |
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. | 3 months | |
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". | 3 months | |
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." | 3 months | |
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. | 3 months |
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