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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD; COPD Exacerbation
• Intervention / Treatment: Other: mHealth Intervention

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hema Ramamurthi; Phone Number: 410-502-9558; Email: hramamu1@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins ALIVE Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care for COPD; Usual care for AECOPD in the JHHCC consists of patient-initiated contact with the clinic for change in respiratory symptoms. Participants will be asked to complete a weekly symptom diary assessment which will be returned to the study staff at every 3-month visits. Participants contacting research staff with a worsening in respiratory symptoms will be referred to their assigned clinical providers.
Experimental: mHealth Intervention; For the mHealth intervention, investigators will use of the eResearch Technology, Inc system (ERT®; Philadelphia, PA) for home-based monitoring of spirometry and respiratory symptoms. In conjunction, wireless sensor-based inhalers will monitor the frequency of rescue inhaler use (Asthmapolis®; Madison, WI). As well, on a daily basis, participants in the early identification group will complete eight respiratory symptom questions from the COPD Assessment Test (CAT). Participants' short acting beta-agonist inhaler use will be monitored by an Asthmapolis Spiroscout Inhaler Tracker. Based on participant responses, flags or electronic notifications can be generated. Based on severity of symptoms and guidelines for recommended care, participants will be instructed to self-manage by optimizing inhaler use (if symptoms are mild) or present for an acute care visit at JHHCC if necessary.	Other: mHealth Intervention; See arm description; Other Names: Home spirometer; Inhaler monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gregory Kirk, MD MHS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2013
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimated): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: HIV; mobile health; spirometry
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HL117349; R34HL117349 (U.S. NIH Grant/Contract)