Clinical Trial: Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: (e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension

Brief Summary: Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) over 6 months in routine clinical practice settings.

Detailed Summary: Remote patient monitoring can lead to improved patient outcomes, including improved quality of life, reduced readmissions, earlier treatment for symptoms detected prior to schedule in-office follow-up visits, improved communications with care providers, increased participation in self-management of disease, and an improved knowledge of their medical conditions . In patients with PAH, daily activity level, as measured using a physical activity monitor for seven consecutive days, correlated with 6-minute walk distance (6MWD). The monitor used in the aforementioned PAH study was positioned on the patients' right upper arm with an armband, as opposed to the more popular and more comfortable wristbands used today, such as the Fitbit Flex. Although the aforementioned PAH study did show a correlation between activity level monitoring and 6MWD, the patients were monitored for only seven days. It is still unknown whether this correlation would exist over a longer trial period and whether patients, their caregivers, and clinicians would find activity level monitoring useful in helping manage PH.
Sponsor: Bayer

Current Primary Outcome:

• 6-minute walk distance (6MWD) [ Time Frame: Baseline ]
  (performed by investigator)
• 6-minute walk distance (6MWD) [ Time Frame: Routine clinic visit after 3 months ]
  (performed by investigator)
• 6-minute walk distance (6MWD) [ Time Frame: Last observation visit after 6 months ]
  (performed by investigator)
• Number of steps per day [ Time Frame: Baseline ]
  (Monitored By Fitbit Flex)
• Number of steps per day [ Time Frame: Routine clinic visit after 3 months ]
  (Monitored By Fitbit Flex)
• Number of steps per day [ Time Frame: Last observation visit after 6 months ]
  (Monitored By Fitbit Flex)

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bayer

Dates:
Date Received: August 10, 2015
Date Started: June 2015
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017