Trial Outcomes & Findings for Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart) (NCT NCT03446313)
NCT ID: NCT03446313
Last Updated: 2025-04-10
Results Overview
Physical activity will be measured by steps per day using activity tracker.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Two months
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
MVN Group
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
Usual Care
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
MVN Group
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
Usual Care
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Failed primary screening
|
3
|
0
|
|
Overall Study
Diagnosed with terminal cancer
|
1
|
0
|
|
Overall Study
Excluded from analysis
|
1
|
1
|
Baseline Characteristics
We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
Baseline characteristics by cohort
| Measure |
MVN Group
n=26 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
Usual Care
n=25 Participants
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
0 Participants
n=7 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
0 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
11 Participants
n=7 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
22 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
14 Participants
n=7 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
29 Participants
n=5 Participants • We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.
|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two monthsPhysical activity will be measured by steps per day using activity tracker.
Outcome measures
| Measure |
Usual Care
n=25 Participants
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
MVN Group
n=26 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
|---|---|---|
|
Steps Per Day
|
6633 Steps/day
Standard Deviation 4684
|
8860 Steps/day
Standard Deviation 5334
|
PRIMARY outcome
Timeframe: 2 monthsPhysical activity will be measured by a six minute walk test.
Outcome measures
| Measure |
Usual Care
n=25 Participants
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
MVN Group
n=26 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
|---|---|---|
|
6MWT
|
429 meters
Standard Error 97
|
430 meters
Standard Error 112
|
SECONDARY outcome
Timeframe: 2 monthsDepression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 (lowest) to 27 (highest), higher score associated with moderate to severe depression.
Outcome measures
| Measure |
Usual Care
n=25 Participants
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
MVN Group
n=26 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
|---|---|---|
|
PHQ-9
|
2 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Total scores for depressive symptoms and exercise self-efficacy were examined from baseline to 2 months. We also examined these variables as possible covariates related to the PA and 6MWT results.
Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0 (lowest) to 100 (highest) with 0 indicating low self-efficacy and 100 indicating high self-efficacy.
Outcome measures
| Measure |
Usual Care
n=25 Participants
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
MVN Group
n=26 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
|---|---|---|
|
Exercise Self-Efficacy Scale (EXSE)
|
9.9 score on a scale
Interval 8.4 to 10.0
|
10 score on a scale
Interval 9.9 to 10.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Surveys were given to participants in the intervention group who agreed to participate in individual interviews.
Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction
Outcome measures
| Measure |
Usual Care
Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff.
|
MVN Group
n=7 Participants
The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day.
|
|---|---|---|
|
Acceptability
Fitbit device
|
—
|
4.83 Score on a scale
Standard Deviation 0.41
|
|
Acceptability
Movn app
|
—
|
4.5 Score on a scale
Standard Deviation 0.71
|
Adverse Events
MVN Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MVN Group
n=32 participants at risk
Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab.
Movn Mobile App: The Movn app will have each participant's personalized instructions for post-cardiac rehab integrated into it including medication reminders, physical activity prompts, educational materials, and patient-reported outcomes.
|
Usual Care
n=28 participants at risk
Participants assigned to the Usual Care group will receive standard instructions and educational handouts after they are discharged from cardiac rehab.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Terminal cancer diagnosis unrelated to study
|
3.1%
1/32 • Number of events 1 • 2 months
|
0.00%
0/28 • 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
Linda Park, Principle Investigator
University of California, San Francisco
Phone: 415-502-6616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place