check_circleStudy 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
  • - 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.
  • - 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
35
Trial Dates
June 2015 - December 2016
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Canada

Primary Outcome

  • 6-minute walk distance (6MWD)
    (performed by investigator)
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • 6-minute walk distance (6MWD)
    (performed by investigator)
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 Questionnaire
    date_rangeTime Frame:
    At baseline, 3 months and 6 months
  • Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
    date_rangeTime Frame:
    At baseline, 3 months and 6 months
  • Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD
    date_rangeTime Frame:
    At baseline, 3 months and 6 months
  • Healthcare provider Satisfaction and Usability questionnaire
    date_rangeTime Frame:
    At 3 months and 6 months
  • Caregiver Satisfaction and Usability questionnaire
    date_rangeTime Frame:
    At 3 months and 6 months
  • Patient Satisfaction and Usability questionnaire
    date_rangeTime 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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