Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
- Conditions
- COPD ExacerbationCOPD
- Interventions
- Other: mHealth Intervention
- Registration Number
- NCT01892566
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
- 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
- Age < 18 years
- Unable/unwilling to provide informed consent
- Failure to present to randomization visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth Intervention 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.
- Primary Outcome Measures
Name Time Method composite clinical outcome of any COPD-related ER visit or hospitalization 6 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins ALIVE Clinic
🇺🇸Baltimore, Maryland, United States