Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV (mReach)
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|ClinicalTrials.gov Identifier: NCT01892566|
Recruitment Status : Unknown
Verified August 2016 by Gregory Kirk, Johns Hopkins University.
Recruitment status was: Recruiting
First Posted : July 4, 2013
Last Update Posted : August 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|COPD COPD Exacerbation||Other: mHealth Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using mHealth to Respond Early to Acute Exacerbations of COPD in HIV (mREACH)|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||January 2017|
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
- composite clinical outcome of any COPD-related ER visit or hospitalization [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892566
|Contact: Hema Ramamurthifirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins ALIVE Clinic||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Hema Ramamurthi 410-502-9558 email@example.com|
|Principal Investigator: Gregory Kirk, MD, PhD|
|Principal Investigator: Michael B Drummond, MD MHS|
|Principal Investigator:||Gregory Kirk, MD MHS||Johns Hopkins University|