This trial is active, not recruiting.

Conditions pulmonary hypertension, hypertension, pulmonary
Treatment correlation assessment
Sponsor Bayer
Start date June 2015
End date November 2016
Trial size 38 participants
Trial identifier NCT02536534, 17926, DBOX 2014/00466


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Patients diagnosed with symptomatic Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and stable on optimal medical therapy who meet the study's eligibility criteria
correlation assessment

Primary Outcomes

6-minute walk distance (6MWD)
time frame: Baseline
6-minute walk distance (6MWD)
time frame: Routine clinic visit after 3 months
6-minute walk distance (6MWD)
time frame: Last observation visit after 6 months
Number of steps per day
time frame: Baseline
Number of steps per day
time frame: Routine clinic visit after 3 months
Number of steps per day
time frame: Last observation visit after 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH), - Age ≥ 18 years, - Baseline 6 Minute Walk Distance (6MWD) a minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial) - WHO Functional Class II or III, - Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no: - decline in World Health Organization (WHO) Function class or, - decline in 6MWD by 15% or, - change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or, - Introduction of parenteral Prostacyclin Analog (PCA) treatment. - Patients provide written informed consent, are able to understand and follow instructions. Exclusion Criteria: - Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band), - Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator, - Enrolled in pulmonary rehabilitation program within last 6 months, - Participating in an interventional study.

Additional Information

Official title (e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bayer.