Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Other: Correlation assessment

• Registration Number: NCT02536534
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06-30
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Primary Completion: 2016-11-25
• Study Completion: 2016-12-21
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PAH and CTEPH	Correlation assessment	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

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD)	At 6 months	(performed by investigator)
Number of steps per day	At 6 months	(monitored by Fitbit Flex)

Secondary Outcome Measures

Name	Time	Method
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