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Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

NCT ID: NCT02536534

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-21

Brief Summary

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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

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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.

Conditions

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Hypertension, Pulmonary

Keywords

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Pulmonary Arterial Hypertension (PAH) Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Correlation assessment

Intervention Type OTHER

Interventions

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Correlation assessment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Canada

Site Status

Countries

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Canada

Other Identifiers

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DBOX 2014/00466

Identifier Type: OTHER

Identifier Source: secondary_id

17926

Identifier Type: -

Identifier Source: org_study_id