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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter

• Registration Number: NCT04369885
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2020-07-01
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-24
• Status Verified: 2021-09
• Results First Submitted: 2021-09-27
• Results First Submitted QC: 2021-09-27
• Results First Posted: 2021-10-28
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home Telemedicine Device	Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter	This arm will receive the intervention of the home telemedicine device for three months.

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.
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."
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".

Trial Locations

Locations (1)

Meadowmont Marsico Lung Research Center; 🇺🇸 Chapel Hill, North Carolina, United States