eRT Remote Health Monitoring

COPD Clinical Trial

Official title:

Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495780
• Other study ID #: eRT RHM
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 20, 2014

Study information

• Verified date: April 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).

Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 20, 2014
• Est. primary completion date: August 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age >40 years.

• Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9

• Smoking history >10 pack-years.

• Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values

• Domestic situation felt to be supportive of remote health monitoring.

• Ability to give informed consent.

Exclusion Criteria:

• Clinical diagnosis of asthma.

• Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.

• Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).

• Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.

• Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.

• Myocardial infarction within 6 weeks of enrolment.

• Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.

• A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Obstructive Lung Disease
• COPD
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Behavioral:
• Remote Health Monitoring
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

Locations

Country	Name	City	State
United States	UCLA David Geffen School of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	eResearch Technology (eRT)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with daily RHM	Compliance with daily RHM as a percentage of study days	1 year
Primary	Integrity of spirometric data	Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.	1 year
Secondary	Rate of adoption of RHM	Time it takes for subjects to become compliant with daily RHM	1 year
Secondary	Treatment adherence	Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)	1 year
Secondary	Time to first COPD exacerbation	Time to first COPD exacerbation as defined by standard criteria.	1 year
Secondary	Number of COPD exacerbations per year		1 year
Secondary	Proportion of subjects experiencing one or more exacerbations		1 year
Secondary	Mean daily FEV1		1 year
Secondary	Mean daily IC		1 year
Secondary	Mean daily activity level		1 year
Secondary	Mean daily SpO2		1 year
Secondary	Daily symptom scores		1 year
Secondary	Number of physician visits		1 year
Secondary	Number of emergency department visits		1 year
Secondary	Number of hospitalizations		1 year
Secondary	Number of days spent in hospital		1 year
Secondary	Health care costs	Inferred health care costs using a standard cost framework model	1 year