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OpenTrials
Completed

NCT Number: NCT04369885

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meadowmont Marsico Lung Research Center

Chapel Hill, North Carolina, 27517, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants With Home Device Measurement Collection Adherence

    Time frame: 3 months

    Percentage of participants achieving >50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months

  2. Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score

    Time frame: 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 outcomes

  1. Percentage of Participants With Individual Survey Domains Score of 4 or Higher

    Time frame: 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.

  2. Median Communication Frequency Survey Score at 3 Months

    Time frame: 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. Median Number of Ideal Daily Questions Score at 3 Months

    Time frame: 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."

  4. Rate of Self-reported COPD Exacerbations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Midmark Corporation
  • Monitored Therapeutics, Inc

Registry information

Official study title

Assessing Adherence to Home Telemedicine in Individuals With COPD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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