Hypertension, Pulmonarye-MOTION PHNCT02536534
Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Correlation assessment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2015to 21 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (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.
Read the 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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Correlation assessment
- Keywords
- Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Correlation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD)
(performed by investigator)
Measured: At baseline
6-minute walk distance (6MWD)
(performed by investigator)
Measured: At 3 months
6-minute walk distance (6MWD)
(performed by investigator)
Measured: At 6 months
Number of steps per day
(monitored by Fitbit Flex)
Measured: At baseline
Number of steps per day
(monitored by Fitbit Flex)
Measured: At 3 months
Number of steps per day
(monitored by Fitbit Flex)
Measured: At 6 months
Secondary outcomes (7)
Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)
Measured: At baseline, 3 months and 6 months
Change in compliance with medication using the Moriky´s Questionnaire
Measured: At baseline, 3 months and 6 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
Measured: At baseline, 3 months and 6 months
Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD
Measured: At baseline, 3 months and 6 months
Healthcare provider Satisfaction and Usability questionnaire
Measured: At 3 months and 6 months
Caregiver Satisfaction and Usability questionnaire
Measured: At 3 months and 6 months
Patient Satisfaction and Usability questionnaire
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study start30 Jun 2015
- Primary completion25 Nov 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536534
- Sponsor's protocol ID
- 17926
- Other IDs
- DBOX 2014/00466
- Acronym
- e-MOTION PH
- Status last verified
- Dec 2017
- First submitted
- 10 Aug 2015
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02536534
- Acronym / sponsor ID
- e-MOTION PH / 17926
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 25 Nov 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PAH and CTEPH | – | Other: Correlation assessmentPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation assessment | Other | Patients with PAH and CTEPH |
Primary outcome
6-minute walk distance (6MWD)
Time frame: At baseline
(performed by investigator)
6-minute walk distance (6MWD)
Time frame: At 3 months
(performed by investigator)
6-minute walk distance (6MWD)
Time frame: At 6 months
(performed by investigator)
Number of steps per day
Time frame: At baseline
(monitored by Fitbit Flex)
Number of steps per day
Time frame: At 3 months
(monitored by Fitbit Flex)
Number of steps per day
Time frame: At 6 months
(monitored by Fitbit Flex)
7 secondary outcomes
Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)
Time frame: At baseline, 3 months and 6 months
Change in compliance with medication using the Moriky´s Questionnaire
Time frame: At baseline, 3 months and 6 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
Time frame: At baseline, 3 months and 6 months
Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD
Time frame: At baseline, 3 months and 6 months
Healthcare provider Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months
Caregiver Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months
Patient Satisfaction and Usability questionnaire
Time frame: At 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (6MWD) (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.