Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-04-23 @ 11:12 PM
Study NCT ID:
NCT02536534
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2015-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-31', 'lastUpdatePostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk distance (6MWD)', 'timeFrame': 'At baseline', 'description': '(performed by investigator)'}, {'measure': '6-minute walk distance (6MWD)', 'timeFrame': 'At 3 months', 'description': '(performed by investigator)'}, {'measure': '6-minute walk distance (6MWD)', 'timeFrame': 'At 6 months', 'description': '(performed by investigator)'}, {'measure': 'Number of steps per day', 'timeFrame': 'At baseline', 'description': '(monitored by Fitbit Flex)'}, {'measure': 'Number of steps per day', 'timeFrame': 'At 3 months', 'description': '(monitored by Fitbit Flex)'}, {'measure': 'Number of steps per day', 'timeFrame': 'At 6 months', 'description': '(monitored by Fitbit Flex)'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)', 'timeFrame': 'At baseline, 3 months and 6 months'}, {'measure': 'Change in compliance with medication using the Moriky´s Questionnaire', 'timeFrame': 'At baseline, 3 months and 6 months'}, {'measure': 'Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD', 'timeFrame': 'At baseline, 3 months and 6 months'}, {'measure': 'Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD', 'timeFrame': 'At baseline, 3 months and 6 months'}, {'measure': 'Healthcare provider Satisfaction and Usability questionnaire', 'timeFrame': 'At 3 months and 6 months'}, {'measure': 'Caregiver Satisfaction and Usability questionnaire', 'timeFrame': 'At 3 months and 6 months'}, {'measure': 'Patient Satisfaction and Usability questionnaire', 'timeFrame': 'At 3 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension (PAH)', 'Chronic Thromboembolic Pulmonary Hypertension (CTEPH)'], 'conditions': ['Hypertension, Pulmonary']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),\n* Age ≥ 18 years,\n* 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)\n* WHO Functional Class II or III,\n* Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no:\n\n * decline in World Health Organization (WHO) Function class or,\n * decline in 6MWD by 15% or,\n * change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or,\n * Introduction of parenteral Prostacyclin Analog (PCA) treatment.\n* Patients provide written informed consent, are able to understand and follow instructions.\n\nExclusion Criteria:\n\n* Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band),\n* 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,\n* Enrolled in pulmonary rehabilitation program within last 6 months,\n* Participating in an interventional study."}, 'identificationModule': {'nctId': 'NCT02536534', 'acronym': 'e-MOTION PH', 'briefTitle': 'Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '(e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '17926'}, 'secondaryIdInfos': [{'id': 'DBOX 2014/00466', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with PAH and CTEPH', 'description': "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", 'interventionNames': ['Other: Correlation assessment']}], 'interventions': [{'name': 'Correlation assessment', 'type': 'OTHER', 'armGroupLabels': ['Patients with PAH and CTEPH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Canada'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}