Trial Outcomes & Findings for A Mobile Health Intervention in Pulmonary Arterial Hypertension (NCT NCT03069716)
NCT ID: NCT03069716
Last Updated: 2021-06-25
Results Overview
Change from baseline mean daily step count at week 12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2021-06-25
Participant Flow
After participant is enrolled, they are given a fitbit device to wear for a 14 day run-in period leading up to the baseline visit. After the baseline visit is completed they are then randomized. Reasons why a participants may have been removed from study prior to randomization include the participant dropping out for personal or medical issues.
Participant milestones
| Measure |
Run-in Participants
participant is enrolled, they are given a fitbit device to wear for a 14 day run-in period leading up to the baseline visit.
|
Smartphone Text Messaging
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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 HR: 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.
|
No Smartphone Text Messaging
Group does not receive personalized, health coaching via "smart" text messages.
Fitbit Charge HR: 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.
|
|---|---|---|---|
|
Run-in Period (2 Weeks)
STARTED
|
49
|
0
|
0
|
|
Run-in Period (2 Weeks)
COMPLETED
|
42
|
0
|
0
|
|
Run-in Period (2 Weeks)
NOT COMPLETED
|
7
|
0
|
0
|
|
Randomized Treatment
STARTED
|
0
|
20
|
22
|
|
Randomized Treatment
COMPLETED
|
0
|
18
|
22
|
|
Randomized Treatment
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Run-in Participants
participant is enrolled, they are given a fitbit device to wear for a 14 day run-in period leading up to the baseline visit.
|
Smartphone Text Messaging
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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 HR: 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.
|
No Smartphone Text Messaging
Group does not receive personalized, health coaching via "smart" text messages.
Fitbit Charge HR: 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.
|
|---|---|---|---|
|
Run-in Period (2 Weeks)
Adverse Event
|
1
|
0
|
0
|
|
Run-in Period (2 Weeks)
Protocol Violation
|
1
|
0
|
0
|
|
Run-in Period (2 Weeks)
Withdrawal by Subject
|
5
|
0
|
0
|
|
Randomized Treatment
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
A Mobile Health Intervention in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Smartphone Text Messaging
n=20 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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 HR: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
Fitbit Charge HR: 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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 Years
n=5 Participants
|
47 Years
n=7 Participants
|
47 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksChange from baseline mean daily step count at week 12.
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Daily Step Count
|
1409 Steps
Interval -32.0 to 2220.0
|
-149 Steps
Interval -1010.0 to 735.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
Change from baseline of six minute walk test distance (meters) at week 12.
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Six Minute Walk Test Distance
|
3 meters
Interval -42.0 to 23.0
|
-6 meters
Interval -36.0 to 26.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
Change from baseline of RV free wall longitudinal strain at week 12.
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Right Ventricle (RV) Strain
|
-0.1 percentage of deformation
Interval -1.6 to 2.0
|
0.4 percentage of deformation
Interval -1.9 to 1.8
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksAll 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
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Percentage of Days Participants Met Their Daily Step Count Goal
|
41 percent of days at goal across group
|
24 percent of days at goal across group
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange in minutes of activity per day between Week 12 and Baseline
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Daily Aerobic Time
|
10 minutes
Interval -36.0 to 58.0
|
-16 minutes
Interval -44.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksQuality 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.
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score
|
-3 units on a scale
Interval -4.8 to 3.0
|
1.0 units on a scale
Interval -2.0 to 3.5
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksSF-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
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Change From Baseline on the SF-36 Mental Component Summary (MCS) Score
|
3.8 units on a scale
Interval 0.9 to 8.7
|
1.5 units on a scale
Interval -9.3 to 3.3
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
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.
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Change From Baseline to Week 12 in Borg Dyspnea Score
|
-1.0 units on a scale
Interval -2.0 to 0.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange in heart rate between Week 12 and Baseline
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Resting Heart Rate
|
0 beats per minute
Interval -7.0 to 4.0
|
0 beats per minute
Interval -7.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
Change from baseline lean mass at week 12.
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Total Lean Mass
|
0.1 kilograms
Interval -1.1 to 1.2
|
0.0 kilograms
Interval -0.6 to 1.1
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
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).
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Insulin Resistance
|
0.3 units on a scale
Interval -0.2 to 0.8
|
0.0 units on a scale
Interval -0.6 to 0.1
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
Change from baseline B-type natriuretic peptide level at week 12.
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
BNP
|
-2 pg/mL
Interval -13.0 to 1.0
|
7 pg/mL
Interval -14.0 to 22.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksSF-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
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Change From Baseline on the SF-36 Physical Component Summary (PCS) Score
|
-0.8 units on a scale
Interval -3.6 to 1.5
|
-0.4 units on a scale
Interval -3.3 to 3.5
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksChange in minutes between Week 12 and Baseline
Outcome measures
| Measure |
Smartphone Text Messaging
n=18 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Minutes of Moderate-vigorous Activity
|
1.6 minutes
Interval -5.1 to 16.1
|
-0.6 minutes
Interval -4.5 to 1.4
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Only 17 participants in the Smartphone Text Messaging arm were analyzed due to research shut downs during COVID. Any assessments requiring an in-person visit were not completed for one participant.
Change in fat volume between Week 12 and Baseline
Outcome measures
| Measure |
Smartphone Text Messaging
n=17 Participants
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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.
|
No Smartphone Text Messaging
n=22 Participants
Group does not receive personalized, health coaching via "smart" text messages.
|
|---|---|---|
|
Visceral Fat Volume
|
-67 mL
Interval -432.0 to 0.0
|
21 mL
Interval -84.0 to 177.0
|
Adverse Events
Smartphone Text Messaging
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
No Smartphone Text Messaging
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Smartphone Text Messaging
n=20 participants at risk
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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 HR: 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.
|
No Smartphone Text Messaging
n=22 participants at risk
Group does not receive personalized, health coaching via "smart" text messages.
Fitbit Charge HR: 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.
|
|---|---|---|
|
Cardiac disorders
Hypertensive urgency
|
5.0%
1/20 • Number of events 1 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
0.00%
0/22 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Medication escalation
|
5.0%
1/20 • Number of events 1 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
0.00%
0/22 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
Other adverse events
| Measure |
Smartphone Text Messaging
n=20 participants at risk
Group receives personalized, health coaching via "smart" text messages.
Smartphone Text Messaging: 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 HR: 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.
|
No Smartphone Text Messaging
n=22 participants at risk
Group does not receive personalized, health coaching via "smart" text messages.
Fitbit Charge HR: 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.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
20.0%
4/20 • Number of events 7 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
4.5%
1/22 • Number of events 1 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 2 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
13.6%
3/22 • Number of events 4 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
|
Cardiac disorders
Edema
|
10.0%
2/20 • Number of events 5 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
18.2%
4/22 • Number of events 12 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 3 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
18.2%
4/22 • Number of events 7 • Adverse Event data collected for 12 weeks from each participant
Definitions of an adverse event and/or serious adverse event, used to collect adverse event information, is in line with clinicaltrials.gov.
|
Additional Information
Dr. Evan L. Brittain
Vanderbilt University Medical Center
Phone: (615) 322-4382
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place