check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
17926
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
35Trial Dates
June 2015 - December 2016Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Canada |
Primary Outcome
- 6-minute walk distance (6MWD)(performed by investigator)date_rangeTime Frame:At baselineenhanced_encryptionNoSafety Issue:
- 6-minute walk distance (6MWD)(performed by investigator)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
- 6-minute walk distance (6MWD)(performed by investigator)date_rangeTime Frame:At 6 months
- Number of steps per day(monitored by Fitbit Flex)date_rangeTime Frame:At baseline
- Number of steps per day(monitored by Fitbit Flex)date_rangeTime Frame:At 3 months
- Number of steps per day(monitored by Fitbit Flex)date_rangeTime Frame:At 6 months
Secondary Outcome
- Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)date_rangeTime Frame:At baseline, 3 months and 6 months
- Change in compliance with medication using the Moriky´s Questionnairedate_rangeTime Frame:At baseline, 3 months and 6 months
- Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWDdate_rangeTime Frame:At baseline, 3 months and 6 months
- Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWDdate_rangeTime Frame:At baseline, 3 months and 6 months
- Healthcare provider Satisfaction and Usability questionnairedate_rangeTime Frame:At 3 months and 6 months
- Caregiver Satisfaction and Usability questionnairedate_rangeTime Frame:At 3 months and 6 months
- Patient Satisfaction and Usability questionnairedate_rangeTime Frame:At 3 months and 6 months
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A