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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD)	(performed by investigator)	At baseline
6-minute walk distance (6MWD)	(performed by investigator)	At 3 months
6-minute walk distance (6MWD)	(performed by investigator)	At 6 months
Number of steps per day	(monitored by Fitbit Flex)	At baseline
Number of steps per day	(monitored by Fitbit Flex)	At 3 months
Number of steps per day	(monitored by Fitbit Flex)	At 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)	At baseline, 3 months and 6 months
Change in compliance with medication using the Moriky´s Questionnaire	At baseline, 3 months and 6 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD	At baseline, 3 months and 6 months
Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD	At baseline, 3 months and 6 months
Healthcare provider Satisfaction and Usability questionnaire	At 3 months and 6 months
Caregiver Satisfaction and Usability questionnaire	At 3 months and 6 months
Patient Satisfaction and Usability questionnaire	At 3 months and 6 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Actual): November 25, 2016
• Study Completion (Actual): December 21, 2016

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Thromboembolic Pulmonary Hypertension (CTEPH); Pulmonary Arterial Hypertension (PAH)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 17926; DBOX 2014/00466 (Other Identifier: Company internal)