Trial Condition(s):
Hypertension, Pulmonary
Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension (e-MOTION PH)
Bayer Identifier:
17926
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Canada | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
(e-MOTION PH) electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 6-minute walk distance (6MWD)(performed by investigator)Timeframe: At baseline
- 6-minute walk distance (6MWD)(performed by investigator)Timeframe: At 3 months
- 6-minute walk distance (6MWD)(performed by investigator)Timeframe: At 6 months
- Number of steps per day(monitored by Fitbit Flex)Timeframe: At baseline
- Number of steps per day(monitored by Fitbit Flex)Timeframe: At 3 months
- Number of steps per day(monitored by Fitbit Flex)Timeframe: At 6 months
Secondary Outcome
- Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)Timeframe: At baseline, 3 months and 6 months
- Change in compliance with medication using the Moriky´s QuestionnaireTimeframe: At baseline, 3 months and 6 months
- Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWDTimeframe: At baseline, 3 months and 6 months
- Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWDTimeframe: At baseline, 3 months and 6 months
- Healthcare provider Satisfaction and Usability questionnaireTimeframe: At 3 months and 6 months
- Caregiver Satisfaction and Usability questionnaireTimeframe: At 3 months and 6 months
- Patient Satisfaction and Usability questionnaireTimeframe: At 3 months and 6 months
Additional Information
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