NCT04369885

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

Completed NA Results posted Last updated 3 November 2021

What this trial tests

NA trial testing Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter in Pulmonary Disease, Chronic Obstructive in 12 participants. Completed in 24 May 2021.

Timeline

1 July 2020

Primary endpoint
24 May 2021

24 May 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	1 July 2020
Primary completion	24 May 2021
Estimated completion	24 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Home Device Measurement Collection Adherence Primary · 3 months

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

Group	Value	95% CI
Home Telemedicine Device	63	25 – 91

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

Group	Value	95% CI
Home Telemedicine Device	57	18 – 90

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

COPD Prevented Spirometry Use

Group	Value	95% CI
Home Telemedicine Device	36	11 – 69

Spirometer Ease of Use

Group	Value	95% CI
Home Telemedicine Device	46	17 – 77

Spirometer Helpful in Symptom Management

Group	Value	95% CI
Home Telemedicine Device	46	17 – 77

Spirometer Helpful for Identifying Health Problems

Group	Value	95% CI
Home Telemedicine Device	46	17 – 77

Spirometer Helpful for Doctor

Group	Value	95% CI
Home Telemedicine Device	55	23 – 83

Spirometer Helpful for Safety & Security

Group	Value	95% CI
Home Telemedicine Device	73	39 – 94

Willingness to Continue Spirometer Use

Group	Value	95% CI
Home Telemedicine Device	45	17 – 77

Likelihood to Recommend Spirometer

Group	Value	95% CI
Home Telemedicine Device	82	48 – 98

Median Communication Frequency Survey Score at 3 Months Secondary · 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".

Group	Value	95% CI
Home Telemedicine Device	3	3 – 3

Median Number of Ideal Daily Questions Score at 3 Months Secondary · 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."

Group	Value	95% CI
Home Telemedicine Device	5	4 – 5

Rate of Self-reported COPD Exacerbations Secondary · 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.

Group	Value	95% CI
Home Telemedicine Device	0.14	0.00 – 0.28

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Home Telemonitoring Program in Individuals With COPD During the Coronavirus Disease 2019 Pandemic: A Pilot Study.
   Rydberg M, Burkett P, Johnson E, Drummond MB. · · 2023 · cited 1× · PMID 37552509 · DOI 10.15326/jcopdf.2023.0431