Adherence Study in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on
      adherence in COPD patients
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is a common disease with substantial associated
      morbidity and mortality. COPD is the third leading cause of death in the US and claimed
      133,965 US lives in 2009. In 2011 12.7 million US adults were estimated to have COPD.
      However, approximately 24 million US adults have evidence of impaired lung function,
      indicating an under diagnosis of COPD. COPD also has a potentially harmful economic impact.
      In 2010, COPD resulted in over 10 million office visits, nearly 1.5 million emergency
      department visits, 700,000 hospitalizations, and 133,575 deaths in the US. In 2010, US total
      medical treatment costs attributed solely to COPD (i.e., excluding comorbidities) were
      estimated to be $32.1 billion with an additional $3.9 billion in COPD costs resulting from
      worker absenteeism. Even in industrialized countries such as the US, where anti-smoking
      initiatives have been relatively successful, the legacy of past smoking behavior in aging
      populations ensures that the COPD burden will unavoidably continue to climb over the next 20
      to 30 years. Adherence rates for inhaled combination therapy is poor (average 3.9 refills per
      year). COPD patients with lower adherence tend to have higher overall healthcare costs, as
      demonstrated in a 24 month study of 33,816 patients in the US, which found: Patients
      continuing therapy had lower costs of care by $3764 compared with patients who had ceased to
      take their maintenance therapy. COPD patients with higher adherence to prescribed regimens
      experienced fewer hospitalizations and lower Medicare costs (-$2185) than those who exhibited
      lower adherence behaviors. Given the poor adherence with inhaled combination therapy seen in
      patients with COPD, and associated morbidity/mortality and economic costs, the present study
      is being conducted to see if medication reminders can be used to improve adherence in this
      population.
    

Intervention name(s): Arm 1: BreatheMate device with application; Arm 2: BreatheMate device without application
Intervention type(s): Device; Device
Intervention description(s): The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. Subjects will receive audio-visual daily reminders (beeps and flashes) on the BreatheMate Bluetooth device. The bluetooth device transmits this data to a cellular phone that is provided to all subjects in the study. Subjects in the intervention group will also receive audio-visual alerts (beeps, flashes) from the bluetooth device to take their medication.; The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. The functionality of audio-visual daily reminders (beeps and flashes) is deactivated for this control group.
The BreatheMate service also includes a cellular phone that will display whether the Bluetooth monitoring device is paired and communicating with the cellular phone. The Bluetooth device will transmit data regarding medication usage to the cellular phone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: chronic obstructive pulmonary disease; COPD; Respiratory; adherence; medication reminders