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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Gregory Kirk, Johns Hopkins University

Sponsor
Johns Hopkins Bloomberg School of Public Health

Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party)
Gregory Kirk, Johns Hopkins University

ClinicalTrials.gov Identifier
NCT01892566

First received: June 27, 2013
Last updated: August 29, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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 Intervention
COPD
COPD Exacerbation

Other : mHealth Intervention

Study Type: Interventional
Study Design: 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)

Further study details as provided by Gregory Kirk, Johns Hopkins University:

Primary Outcome Measures

  • 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.

Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name:
  • Home spirometer
  • Inhaler monitor

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 100 Years  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892566

Contacts

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

Locations

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

Principal Investigator: Gregory Kirk, MD MHS Johns Hopkins University
More Information

More Information


Responsible Party: Gregory Kirk, Professor, Johns Hopkins University  
ClinicalTrials.gov Identifier: NCT01892566   History of Changes  
Other Study ID Numbers: HL117349  
  R34HL117349  
Study First Received: June 27, 2013  
Last Updated: August 29, 2016  

Keywords provided by Gregory Kirk, Johns Hopkins University:

HIV
mobile health
spirometry

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.