Trial Outcomes & Findings for Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT) (NCT NCT02664610)

NCT ID: NCT02664610

Last Updated: 2023-06-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2023-06-05

Participant Flow

Participant milestones

Measure	No Text Messages, Hypertensive Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Text Messages, Hypertensive Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Overall Study STARTED	46	48
Overall Study COMPLETED	32	41
Overall Study NOT COMPLETED	14	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)

Baseline characteristics by cohort

Measure	No Text Messages, Hypertensive n=46 Participants Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Text Messages, Hypertensive n=48 Participants Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages	Total n=94 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 9.8 • n=5 Participants	58 years STANDARD_DEVIATION 8.5 • n=7 Participants	58 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	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	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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
Region of Enrollment United States	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Outcome measures

Measure	No Text Messages, Hypertensive n=32 Participants Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Text Messages, Hypertensive n=41 Participants Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Mean Change in Systolic Blood Pressure 6 months	146.7 mmHg Standard Deviation 20.5	147.2 mmHg Standard Deviation 21.8
Mean Change in Systolic Blood Pressure Change from baseline	-14.4 mmHg Standard Deviation 26.4	-11.3 mmHg Standard Deviation 22.9
Mean Change in Systolic Blood Pressure Baseline	162.2 mmHg Standard Deviation 20.5	160.7 mmHg Standard Deviation 23.6

SECONDARY outcome

Timeframe: Baseline to 6 months

Outcome measures

Measure	No Text Messages, Hypertensive n=32 Participants Participants who have high blood pressure, who are randomized to health information (do not receive text messages).	Text Messages, Hypertensive n=41 Participants Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
Mean Change in Diastolic Blood Pressure Change from baseline	-9.5 mmHg Standard Deviation 12.9	-8.6 mmHg Standard Deviation 15.9
Mean Change in Diastolic Blood Pressure Baseline	99.2 mmHg Standard Deviation 17.8	99.0 mmHg Standard Deviation 11.8
Mean Change in Diastolic Blood Pressure 6 months	88.5 mmHg Standard Deviation 11.5	89.4 mmHg Standard Deviation 13.9

Adverse Events

No Text Messages, Hypertensive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Text Messages, Hypertensive

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

Lesli Skolarus

University of Michigan

Phone: 734-936-9075

Email: lerusche@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place