Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension (e-MOTION PH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02536534
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Other: Correlation assessment

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: (e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : November 25, 2016
Actual Study Completion Date : December 21, 2016


Group/Cohort Intervention/treatment
Patients with PAH and CTEPH
Patients diagnosed with symptomatic Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and stable on optimal medical therapy who meet the study's eligibility criteria
Other: Correlation assessment



Primary Outcome Measures :
  1. 6-minute walk distance (6MWD) [ Time Frame: At baseline ]
    (performed by investigator)

  2. 6-minute walk distance (6MWD) [ Time Frame: At 3 months ]
    (performed by investigator)

  3. 6-minute walk distance (6MWD) [ Time Frame: At 6 months ]
    (performed by investigator)

  4. Number of steps per day [ Time Frame: At baseline ]
    (monitored by Fitbit Flex)

  5. Number of steps per day [ Time Frame: At 3 months ]
    (monitored by Fitbit Flex)

  6. Number of steps per day [ Time Frame: At 6 months ]
    (monitored by Fitbit Flex)


Secondary Outcome Measures :
  1. Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH) [ Time Frame: At baseline, 3 months and 6 months ]
  2. Change in compliance with medication using the Moriky´s Questionnaire [ Time Frame: At baseline, 3 months and 6 months ]
  3. 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 ]
  4. Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD [ Time Frame: At baseline, 3 months and 6 months ]
  5. Healthcare provider Satisfaction and Usability questionnaire [ Time Frame: At 3 months and 6 months ]
  6. Caregiver Satisfaction and Usability questionnaire [ Time Frame: At 3 months and 6 months ]
  7. Patient Satisfaction and Usability questionnaire [ Time Frame: At 3 months and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Canadian patients are eligible for the study if they have been diagnosed with symptomatic Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and are stable on optimal medical therapy and who meet the study's eligibility criteria
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536534


Locations
Layout table for location information
Canada
Multiple Locations, Canada
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02536534     History of Changes
Other Study ID Numbers: 17926
DBOX 2014/00466 ( Other Identifier: Company internal )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by Bayer:
Pulmonary Arterial Hypertension (PAH)
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases