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.
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.
Study Type
OBSERVATIONAL
Enrollment
35
Unnamed facility
Multiple Locations, Canada
6-minute walk distance (6MWD)
(performed by investigator)
Time frame: At baseline
6-minute walk distance (6MWD)
(performed by investigator)
Time frame: At 3 months
6-minute walk distance (6MWD)
(performed by investigator)
Time frame: At 6 months
Number of steps per day
(monitored by Fitbit Flex)
Time frame: At baseline
Number of steps per day
(monitored by Fitbit Flex)
Time frame: At 3 months
Number of steps per day
(monitored by Fitbit Flex)
Time frame: At 6 months
Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)
Time frame: At baseline, 3 months and 6 months
Change in compliance with medication using the Moriky´s Questionnaire
Time frame: At baseline, 3 months and 6 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
Time frame: At baseline, 3 months and 6 months
Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD
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Time frame: At baseline, 3 months and 6 months
Healthcare provider Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months
Caregiver Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months
Patient Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months