Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

NCT02536534 | Completed

• 2 other identifiers: 17926DBOX 2014/00466
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (1)

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

Interventions

Correlation assessment OTHER

Patients with PAH and CTEPH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: September 1, 2015
• Study Start: June 30, 2015
• Primary Completion: November 25, 2016
• Study Completion: December 21, 2016
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

CA (1)