Trial Outcomes & Findings for Activity Trackers for Improving BP (NCT NCT03325426)

Results Overview

Change in mean systolic BP is modeled using all blood pressure data points collected between baseline and month 12 to provide an average change over time, accounting for repeated values from patients using a mixed linear regression approach.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

Between baseline and month 12

Results posted on

2024-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Six months of usual care without a device, followed by crossover to use of the physical activity tracker	Physical Activity Tracker FitBit: Daily use of physical activity tracker coupled with biweekly provider telemonitoring and feedback for 12 months
Overall Study STARTED	21	42
Overall Study COMPLETED	11	18
Overall Study NOT COMPLETED	10	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Activity Trackers for Improving BP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Arm n=21 Participants Usual care x 6 months, then crossover to physical activity tracker x 6 months	Intervention Arm n=42 Participants Physical activity tracker x 12 months	Total n=63 Participants Total of all reporting groups
Age, Continuous	18.0 years STANDARD_DEVIATION 4.4 • n=5 Participants	17.6 years STANDARD_DEVIATION 3.9 • n=7 Participants	17.7 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	27 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	23 Participants n=7 Participants	33 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
Region of Enrollment United States	21 participants n=5 Participants	42 participants n=7 Participants	63 participants n=5 Participants
Estimated glomerular filtration rate	81 mL/min/1.73 m^2 STANDARD_DEVIATION 35 • n=5 Participants	81 mL/min/1.73 m^2 STANDARD_DEVIATION 25 • n=7 Participants	81 mL/min/1.73 m^2 STANDARD_DEVIATION 28 • n=5 Participants

PRIMARY outcome

Timeframe: Between baseline and month 12

Change in mean systolic BP is modeled using all blood pressure data points collected between baseline and month 12 to provide an average change over time, accounting for repeated values from patients using a mixed linear regression approach.

Outcome measures

Outcome measures
Measure	Usual Care n=11 Participants Usual care x 6 months, then crossover to physical activity tracker x 6 months	Physical Activity Tracker n=18 Participants Physical activity tracker x 12 months
Change in Mean Office Systolic BP	0.3 mmHg Interval -10.0 to 10.0	-4 mmHg Interval -14.0 to 6.0

PRIMARY outcome

Timeframe: Between baseline and month 6

Change in mean systolic BP using blood pressure data points collected between baseline and month 6 to provide an average change over time

Outcome measures

Outcome measures
Measure	Usual Care n=18 Participants Usual care x 6 months, then crossover to physical activity tracker x 6 months	Physical Activity Tracker n=26 Participants Physical activity tracker x 12 months
Change in Mean Office Systolic BP	3.0 mmHg Interval -2.5 to 8.4	-2.3 mmHg Interval -6.5 to 1.8

SECONDARY outcome

Timeframe: Months 0-12

Rate of study participant retention

Outcome measures

Outcome measures
Measure	Usual Care n=21 Participants Usual care x 6 months, then crossover to physical activity tracker x 6 months	Physical Activity Tracker n=42 Participants Physical activity tracker x 12 months
Number of Participants Retained	11 Participants	18 Participants

SECONDARY outcome

Timeframe: Months 0-12

Weights were measured in clinic using a standardized scale. Z score of 0 represents the population mean. A z-score of +1.96 represents the 95th percentile of weight and -1.96 represents the 5th percentile of weight. Change in weight (z-score) is modeled using all weight data points collected between baseline and month 12 to provide an average change over time accounting for repeated values from patients using a mixed linear regression approach.

Outcome measures

Outcome measures
Measure	Usual Care n=11 Participants Usual care x 6 months, then crossover to physical activity tracker x 6 months	Physical Activity Tracker n=18 Participants Physical activity tracker x 12 months
Change in Weight (Z-score)	-0.20 Z-score Interval -0.34 to -0.07	-0.06 Z-score Interval -0.17 to 0.05

Adverse Events

Usual Care Arm (mo. 0-6)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Arm (mo. 6-12)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elaine Ku

UCSF

Phone: 415-502-7760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place