Trial Outcomes & Findings for Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension (NCT NCT01255436)

NCT ID: NCT01255436

Last Updated: 2017-02-23

Results Overview

Absolute change in systolic blood pressure from baseline to 12 weeks

Recruitment status

COMPLETED

Study phase

Target enrollment

700 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2017-02-23

Participant Flow

Patients with hypertension, maintained on blood pressure-lowering medications, who fulfilled the inclusion/exclusion criteria, and consulting at the General Medicine outpatient continuity clinic were recruited over a period of 6 months.

Participant milestones

Participant milestones
Measure	SMS Text Reminders 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Study STARTED	333	329
Overall Study COMPLETED	151	135
Overall Study NOT COMPLETED	182	194

Reasons for withdrawal

Reasons for withdrawal
Measure	SMS Text Reminders 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Study Lost to Follow-up	178	191
Overall Study Death, stroke, or MI	4	3

Baseline Characteristics

Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMS Text Reminders n=333 Participants 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=329 Participants Usual care consisting of clinic visits, physician advice and medication prescriptions	Total n=662 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	59.6 years STANDARD_DEVIATION 11.1 • n=7 Participants	59.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Gender Female	220 Participants n=5 Participants	212 Participants n=7 Participants	432 Participants n=5 Participants
Gender Male	113 Participants n=5 Participants	117 Participants n=7 Participants	230 Participants n=5 Participants
Employment Status Unemployed	242 participants n=5 Participants	238 participants n=7 Participants	480 participants n=5 Participants
Employment Status Employed	70 participants n=5 Participants	65 participants n=7 Participants	135 participants n=5 Participants
Employment Status Retired	21 participants n=5 Participants	26 participants n=7 Participants	47 participants n=5 Participants
Educational Attainment No formal education	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Educational Attainment Elementary	84 participants n=5 Participants	79 participants n=7 Participants	163 participants n=5 Participants
Educational Attainment High school	145 participants n=5 Participants	152 participants n=7 Participants	297 participants n=5 Participants
Educational Attainment College	89 participants n=5 Participants	82 participants n=7 Participants	171 participants n=5 Participants
Educational Attainment Other	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Time in years since diagnosis of hypertension	8.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	8.6 years STANDARD_DEVIATION 8.2 • n=7 Participants	8.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Number of prescribed drugs for hypertension	2 medications n=5 Participants	2 medications n=7 Participants	2 medications n=5 Participants
Number of prescribed maintenance medications	3 medications n=5 Participants	4 medications n=7 Participants	4 medications n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Only participants who completed follow up and had evaluable data were analyzed.

Absolute change in systolic blood pressure from baseline to 12 weeks

Outcome measures

Outcome measures
Measure	SMS Text Reminders n=151 Participants 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=135 Participants Usual care consisting of clinic visits, physician advice and medication prescriptions
Mean Absolute Change in Systolic Blood Pressure After 12 Weeks	-13.7 mmHg Standard Deviation 19.1	-9.5 mmHg Standard Deviation 25.7

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Only patients who completed follow up and had evaluable data were analyzed.

Absolute change in diastolic blood pressure from baseline to 12 weeks

Outcome measures

Outcome measures
Measure	SMS Text Reminders n=151 Participants 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=135 Participants Usual care consisting of clinic visits, physician advice and medication prescriptions
Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks	-6.2 mmHg Standard Deviation 11.1	-4.7 mmHg Standard Deviation 12.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Only patients who completed follow up and had evaluable data were analyzed.

The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)

Outcome measures

Outcome measures
Measure	SMS Text Reminders n=151 Participants 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=135 Participants Usual care consisting of clinic visits, physician advice and medication prescriptions
Medication Adherence Rate	59.6 percentage of participants	47.4 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Only patients who completed follow up and had evaluable data were analyzed.

The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks

Outcome measures

Outcome measures
Measure	SMS Text Reminders n=151 Participants 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=135 Participants Usual care consisting of clinic visits, physician advice and medication prescriptions
Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks	68.2 percentage of participants	54.1 percentage of participants

Adverse Events

SMS Text Reminders

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

No SMS Text Reminders

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SMS Text Reminders n=333 participants at risk 2 SMS text reminders per week for 12 weeks	No SMS Text Reminders n=329 participants at risk Usual care consisting of clinic visits, physician advice and medication prescriptions
General disorders All-cause mortality	0.90% 3/333 • Number of events 3	0.61% 2/329 • Number of events 2
Cardiac disorders Myocardial Infarction	0.00% 0/333	0.30% 1/329 • Number of events 1
Nervous system disorders Stroke	0.30% 1/333 • Number of events 1	0.00% 0/329

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lia M. Palileo

University of the Philippines Manila

Phone: 6325679740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place