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

NCT01892566 | Completed DMC

• 2 other identifiers: HL117349R34HL117349
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; COPD Exacerbation

Keywords

HIV; mobile health; spirometry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Usual care for COPD

NO INTERVENTION

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.

mHealth Intervention

EXPERIMENTAL

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

Interventions

mHealth Intervention OTHER

See arm description

Also known as: Home spirometer, Inhaler monitor

mHealth Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Unable/unwilling to provide informed consent
• Failure to present to randomization visit

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins ALIVE Clinic

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory Kirk, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 4, 2013
• Study Start: September 26, 2013
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

US (1)