Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV

COPD Clinical Trial

— mReach  

Official title:

Using mHealth to Respond Early to Acute Exacerbations of COPD in HIV (mREACH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892566
• Other study ID #: HL117349
• Secondary ID: R34HL117349
• Status: Completed
• Phase: N/A
• Start date: September 26, 2013
• Est. completion date: May 9, 2022

Study information

• Verified date: July 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators propose to develop methods to improve early identification of acute exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that earlier identification of acute exacerbations through in-home monitoring of respiratory symptoms, lung function and medication usage will allow appropriate intervention to reduce the morbidity associated with AECOPD. Therefore, the investigators propose using innovative mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly under-recognized among HIV-infected persons. In this application, among HIV-infected individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden of AECOPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• HIV infected

• Has an established longitudinal care provider in Baltimore, MD

• Confirmed COPD defined as post-bronchodilator FEV1/FVC<0.70

• Stable residence for duration of 6 month intervention

Exclusion Criteria:

• Age < 18 years

• Unable/unwilling to provide informed consent

• Failure to present to randomization visit

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• mHealth Intervention
See arm description

Locations

Country	Name	City	State
United States	Johns Hopkins ALIVE Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite clinical outcome of any COPD-related ER visit or hospitalization	Investigators will assess both patient-reported and clinical outcomes. Both the usual care and intervention arms will complete a paper version of the CAT on a weekly basis. Investigators will compare symptom-free days and time to symptom resolution after an AECOPD. Investigators will also evaluate the composite clinical outcome of any COPD-related ER visit or hospitalization. Additionally, investigators will determine the feasibility, participant acceptability (defined as retention in the study, daily usage of device), and monitoring intensity needed for future trials. Investigators will also collect preliminary data on the number of contacts made to the participant based on automated flags, response of HIV provider, change to medical regimen for COPD care, hospitalization and clinic visits. Investigators will assess changes in respiratory specific quality of life measures using the St. George's Respiratory Questionnaire each month.	6 months