Pulmonary Arterial HypertensionmHealthNCT03069716
A Mobile Health Intervention in Pulmonary Arterial Hypertension
A study testing Smartphone Text Messaging and Fitbit Charge HR in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension
- What is being tested?
- Smartphone Text Messaging and Fitbit Charge HR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 24 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Aged 18 or older.
- Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
- Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.
Who cannot join
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
- Pregnancy.
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- Forced vital capacity <70% predicted.
- Functional class IV heart failure.
- Requirement of > 1 diuretic adjustment in the prior three months.
- Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.
Read the detailed description
Patients with pulmonary arterial hypertension (PAH) have severely reduced exercise capacity and reduced quality of life. At diagnosis, most PAH patients are New York Heart Association (NYHA) functional class III with symptoms of fatigue and shortness of breath with less than ordinary activity. Physical activity confers multiple benefits relevant to PAH pathophysiology including improvements in endothelial function, energy metabolism, and right ventricular (RV) function. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) improvement that exceeds the effect of medications.
The goal of this proposal is to adapt and test the feasibility of our mHealth intervention to increase physical activity in a geographically diverse PAH population. In secondary aims, we will assess conventional PAH trial outcomes (6MWD, quality of life) and physiologic mechanisms by which increasing activity may improve exercise capacity.
The investigator hypothesizes that an mHealth intervention is feasible and will increase physical activity in subjects with PAH. This study proposes a randomized trial of unblinded step tracking with smart texts tracking for 12 weeks. Participants will wear a display-free triaxial accelerometer, which will continuously transmit data to a compatible smartphone (owned by 75% of our PAH population). Efficacy endpoints have been selected to mirror FDA criteria for drug approval in PAH. The following aims will be tested:
Aim 1: To test the feasibility of an mHealth intervention to increase step counts in patients with PAH. Fifty PAH patients will be randomized to the mHealth intervention or usual activity for 12 weeks. The primary endpoint will be daily step count during Week 12. Secondary endpoints will assess step target achievement, daily activity time, and aerobic time. The fidelity of data collection and text transmission will also be assessed.
Aim 2: To examine the effect of an mHealth intervention on exercise capacity and quality of life. Participants will complete a six minute walk test and the emPHasis-10 questionnaire at baseline and 12 weeks. The primary endpoint will be six minute walk distance. Secondary endpoints will be emPHasis-10 quality of life scale score, Borg dyspnea score, and resting heart rate.
Aim 3: To examine the effect of an mHealth intervention on mechanisms of improved exercise capacity. Subjects will undergo echocardiography, blood draw, and body composition assessment. The primary endpoint will be RV longitudinal strain. Secondary endpoints will be the homeostatic model assessment of insulin resistance, lean muscle and fat mass, and B-type natriuretic peptide.
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Associated Pulmonary Arterial Hypertension
- Being tested
- Smartphone Text Messaging, Fitbit Charge HR
- Keywords
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Text MessagingDevice
Also called mHealth activity intervention
A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Fitbit Charge HRDevice
Also called Digital Activity Tracker
The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Text Messaging | Experimental | Group receives personalized, health coaching via "smart" text messages. Receives: Device: Smartphone Text Messaging; Device: Fitbit Charge HR |
| No Smartphone Text Messaging | Other | Group does not receive personalized, health coaching via "smart" text messages. Receives: Device: Fitbit Charge HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Step Count
Change from baseline mean daily step count at week 12.
Measured: Baseline to 12 weeks
Secondary outcomes (14)
Six Minute Walk Test Distance
Change from baseline of six minute walk test distance (meters) at week 12.
Measured: Baseline to 12 weeks
Right Ventricle (RV) Strain
Change from baseline of RV free wall longitudinal strain at week 12.
Measured: Baseline to 12 weeks
Percentage of Days Participants Met Their Daily Step Count Goal
All participants were provided with an Fitbit Charge Heart Rate mobile device to monitor daily step counts, activity time, and aerobic time. The daily goal was communicated via text to the intervention group and was the baseline step count average for the control group. Increased daily goal attainment indicates increased activity level
Measured: Baseline to 12 weeks
Daily Aerobic Time
Change in minutes of activity per day between Week 12 and Baseline
Measured: Baseline to 12 weeks
Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score
Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 12 minus the value at Baseline. The Week 12 value was defined as the last assessment at or prior to Week 12.
Measured: Baseline to 12 weeks
Change From Baseline on the SF-36 Mental Component Summary (MCS) Score
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health
Measured: Baseline to 12 weeks
Change From Baseline to Week 12 in Borg Dyspnea Score
The Borg Dyspnea score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal" shortness of breath). The scale was completed at the beginning and conclusion of each 6-minute walk test at baseline and at Week 12. Median change from baseline in scoring was reported.
Measured: Baseline to 12 weeks
Resting Heart Rate
Change in heart rate between Week 12 and Baseline
Measured: Baseline to 12 weeks
Total Lean Mass
Change from baseline lean mass at week 12.
Measured: Baseline to 12 weeks
Insulin Resistance
Insulin resistance measured by the Homeostatic Model Assessment for Insulin Resistance insulin resistance score (HOMA-IR) utilizing the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
Measured: Baseline to 12 weeks
BNP
Change from baseline B-type natriuretic peptide level at week 12.
Measured: Baseline to 12 weeks
Change From Baseline on the SF-36 Physical Component Summary (PCS) Score
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health
Measured: Baseline to 12 weeks
Minutes of Moderate-vigorous Activity
Change in minutes between Week 12 and Baseline
Measured: Baseline to 12 Weeks
Visceral Fat Volume
Change in fat volume between Week 12 and Baseline
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start2 Aug 2017
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur after a two-week run-in period to improve ability to identify a true baseline step count and account for potential dropout. Participants will be assigned to either the smartphone text messaging or no smartphone text messaging arms in a random manner until 25 participants are enrolled into each arm. Permuted block randomization stratified by functional class (I/II vs. III) will be used to ensure approximate balance of treatment groups within each stratum over time. Randomization will be performed in small blocks, which vary in size. Investigators will be unaware of the size or order of the blocks. Randomization will occur through REDCap by a study coordinator. Although the texting intervention will end after Week 12, subjects in both groups will be asked to continue wearing the Fitbit Charge HR device for an additional 3 weeks to determine whether withdrawal of the texting intervention results in a reduction in step counts.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Evan Brittain, Vanderbilt University Medical Center
- Investigators
- Evan Brittain, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069716
- Sponsor's protocol ID
- IRB #162004
- Acronym
- mHealth
- Status last verified
- Jun 2021
- First submitted
- 21 Feb 2017
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.
PubMed 26553211Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.
PubMed 22576635Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
PubMed 18029834Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
PubMed 16982941Hemnes AR, Silverman-Lloyd LG, Huang S, MacKinnon G, Annis J, Whitmore CS, Mallugari R, Oggs RN, Hekmat R, Shan R, Huynh PP, Yu C, Martin SS, Blaha MJ, Brittain EL. A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. Chest. 2021 Sep;160(3):1042-1052. doi: 10.1016/j.chest.2021.04.012. Epub 2021 Apr 17.
PubMed 33878341
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Intervention in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03069716
- Acronym / sponsor ID
- mHealth / IRB #162004
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Associated Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.
Detailed description
Patients with pulmonary arterial hypertension (PAH) have severely reduced exercise capacity and reduced quality of life. At diagnosis, most PAH patients are New York Heart Association (NYHA) functional class III with symptoms of fatigue and shortness of breath with less than ordinary activity. Physical activity confers multiple benefits relevant to PAH pathophysiology including improvements in endothelial function, energy metabolism, and right ventricular (RV) function. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) improvement that exceeds the effect of medications.
The goal of this proposal is to adapt and test the feasibility of our mHealth intervention to increase physical activity in a geographically diverse PAH population. In secondary aims, we will assess conventional PAH trial outcomes (6MWD, quality of life) and physiologic mechanisms by which increasing activity may improve exercise capacity.
The investigator hypothesizes that an mHealth intervention is feasible and will increase physical activity in subjects with PAH. This study proposes a randomized trial of unblinded step tracking with smart texts tracking for 12 weeks. Participants will wear a display-free triaxial accelerometer, which will continuously transmit data to a compatible smartphone (owned by 75% of our PAH population). Efficacy endpoints have been selected to mirror FDA criteria for drug approval in PAH. The following aims will be tested:
Aim 1: To test the feasibility of an mHealth intervention to increase step counts in patients with PAH. Fifty PAH patients will be randomized to the mHealth intervention or usual activity for 12 weeks. The primary endpoint will be daily step count during Week 12. Secondary endpoints will assess step target achievement, daily activity time, and aerobic time. The fidelity of data collection and text transmission will also be assessed.
Aim 2: To examine the effect of an mHealth intervention on exercise capacity and quality of life. Participants will complete a six minute walk test and the emPHasis-10 questionnaire at baseline and 12 weeks. The primary endpoint will be six minute walk distance. Secondary endpoints will be emPHasis-10 quality of life scale score, Borg dyspnea score, and resting heart rate.
Aim 3: To examine the effect of an mHealth intervention on mechanisms of improved exercise capacity. Subjects will undergo echocardiography, blood draw, and body composition assessment. The primary endpoint will be RV longitudinal strain. Secondary endpoints will be the homeostatic model assessment of insulin resistance, lean muscle and fat mass, and B-type natriuretic peptide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will occur after a two-week run-in period to improve ability to identify a true baseline step count and account for potential dropout. Participants will be assigned to either the smartphone text messaging or no smartphone text messaging arms in a random manner until 25 participants are enrolled into each arm. Permuted block randomization stratified by functional class (I/II vs. III) will be used to ensure approximate balance of treatment groups within each stratum over time. Randomization will be performed in small blocks, which vary in size. Investigators will be unaware of the size or order of the blocks. Randomization will occur through REDCap by a study coordinator. Although the texting intervention will end after Week 12, subjects in both groups will be asked to continue wearing the Fitbit Charge HR device for an additional 3 weeks to determine whether withdrawal of the texting intervention results in a reduction in step counts.
| Arm | Type | Receives |
|---|---|---|
| Smartphone Text Messaging | Experimental | Device: Smartphone Text Messaging, Device: Fitbit Charge HRGroup receives personalized, health coaching via "smart" text messages. |
| No Smartphone Text Messaging | Other | Device: Fitbit Charge HRGroup does not receive personalized, health coaching via "smart" text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or older.
- Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
- Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.
Key exclusion criteria (7 listed)
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
- Pregnancy.
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- Forced vital capacity <70% predicted.
- Functional class IV heart failure.
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 |
|---|---|---|
| Smartphone Text MessagingAlso: mHealth activity interventionA HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. | Device | Smartphone Text Messaging |
| Fitbit Charge HRAlso: Digital Activity TrackerThe Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive. | Device | No Smartphone Text Messaging, Smartphone Text Messaging |
Primary outcome
Daily Step Count
Time frame: Baseline to 12 weeks
Change from baseline mean daily step count at week 12.
14 secondary outcomes
Six Minute Walk Test Distance
Time frame: Baseline to 12 weeks
Right Ventricle (RV) Strain
Time frame: Baseline to 12 weeks
Percentage of Days Participants Met Their Daily Step Count Goal
Time frame: Baseline to 12 weeks
Daily Aerobic Time
Time frame: Baseline to 12 weeks
Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score
Time frame: Baseline to 12 weeks
Change From Baseline on the SF-36 Mental Component Summary (MCS) Score
Time frame: Baseline to 12 weeks
Change From Baseline to Week 12 in Borg Dyspnea Score
Time frame: Baseline to 12 weeks
Resting Heart Rate
Time frame: Baseline to 12 weeks
Total Lean Mass
Time frame: Baseline to 12 weeks
Insulin Resistance
Time frame: Baseline to 12 weeks
BNP
Time frame: Baseline to 12 weeks
Change From Baseline on the SF-36 Physical Component Summary (PCS) Score
Time frame: Baseline to 12 weeks
Minutes of Moderate-vigorous Activity
Time frame: Baseline to 12 Weeks
Visceral Fat Volume
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26553211Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.
- Background: PubMed 22576635Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.
- Background: PubMed 18029834Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
- Background: PubMed 16982941Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
- Derived from this study: PubMed 33878341Hemnes AR, Silverman-Lloyd LG, Huang S, MacKinnon G, Annis J, Whitmore CS, Mallugari R, Oggs RN, Hekmat R, Shan R, Huynh PP, Yu C, Martin SS, Blaha MJ, Brittain EL. A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. Chest. 2021 Sep;160(3):1042-1052. doi: 10.1016/j.chest.2021.04.012. Epub 2021 Apr 17.
- Individual participant dataSharing planned: No
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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.
Evan Brittain, MD, MSc principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Text Messaging and Fitbit Charge HR in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
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 4 inclusion and 7 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 25 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daily Step Count (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069716, which also lists 5 linked publications.
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 25 Jun 2021.