Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

— e-MOTION PH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536534
• Other study ID #: 17926
• Secondary ID: DBOX 2014/00466
• Status: Completed
• Phase: N/A
• First received: August 10, 2015
• Last updated: December 19, 2017
• Start date: June 30, 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 21, 2016
• Est. primary completion date: November 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Other:
• Correlation assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk distance (6MWD)	(performed by investigator)	At baseline
Primary	6-minute walk distance (6MWD)	(performed by investigator)	At 3 months
Primary	6-minute walk distance (6MWD)	(performed by investigator)	At 6 months
Primary	Number of steps per day	(monitored by Fitbit Flex)	At baseline
Primary	Number of steps per day	(monitored by Fitbit Flex)	At 3 months
Primary	Number of steps per day	(monitored by Fitbit Flex)	At 6 months
Secondary	Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)		At baseline, 3 months and 6 months
Secondary	Change in compliance with medication using the Moriky´s Questionnaire		At baseline, 3 months and 6 months
Secondary	Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD		At baseline, 3 months and 6 months
Secondary	Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD		At baseline, 3 months and 6 months
Secondary	Healthcare provider Satisfaction and Usability questionnaire		At 3 months and 6 months
Secondary	Caregiver Satisfaction and Usability questionnaire		At 3 months and 6 months
Secondary	Patient Satisfaction and Usability questionnaire		At 3 months and 6 months

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