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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Gregory Kirk, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation Other: mHealth Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Hema Ramamurthi 410-502-9558 hramamu1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins ALIVE Clinic Recruiting
Baltimore, Maryland, United States, 21287
Contact: Hema Ramamurthi    410-502-9558    hramamu1@jhu.edu   
Principal Investigator: Gregory Kirk, MD, PhD         
Principal Investigator: Michael B Drummond, MD MHS         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Gregory Kirk, MD MHS Johns Hopkins University

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Responsible Party: Gregory Kirk, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01892566     History of Changes
Other Study ID Numbers: HL117349
R34HL117349 ( U.S. NIH Grant/Contract )
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Keywords provided by Gregory Kirk, Johns Hopkins University:
HIV
mobile health
spirometry
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases