Clinical trial NCT04369885: Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Assessing Adherence to Home Telemedicine in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: home telemedicine
home spirometer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Midmark Corporation
name: Monitored Therapeutics, Inc
First posted: 2020-04-30
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Home Device Measurement Collection Adherence
timeFrame: 3 months
measure: Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants With Individual Survey Domains Score of 4 or Higher
timeFrame: 3 months
measure: Median Communication Frequency Survey Score at 3 Months
timeFrame: 3 months
measure: Median Number of Ideal Daily Questions Score at 3 Months
timeFrame: 3 months
measure: Rate of Self-reported COPD Exacerbations
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Meadowmont Marsico Lung Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael B Drummond, MD
role: PRINCIPAL_INVESTIGATOR
References: