Study Completed

Hypertension, Pulmonary

Bayer Identifier:

17926

ClinicalTrials.gov Identifier:

NCT02536534

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

Both

Age

18 - N/A

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

June 2015 - December 2016

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Canada

Primary Outcome

6-minute walk distance (6MWD)
(performed by investigator)
Time Frame:
At baseline
Safety Issue:
No
6-minute walk distance (6MWD)
(performed by investigator)
Time Frame:
At 3 months
Safety Issue:
No
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

Secondary Outcome

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
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

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

N/A

Additional Information

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