Trial Outcomes & Findings for A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting (NCT NCT03986931)
NCT ID: NCT03986931
Last Updated: 2025-01-22
Results Overview
The difference between the groups in the change from baseline to 12 months in systolic blood pressure in mm Hg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
535 participants
Primary outcome timeframe
12 months
Results posted on
2025-01-22
Participant Flow
The participant must have an average research blood pressure \> 145 mmHg systolic or \> 95 mmHg diastolic measured by a research team member on the day of enrollment to be eligible to continue participation. 535 participants signed a consent form. 114 participants did not pass the additional blood pressure screening and were not randomized. 1 participant died prior to randomization. 420 participants were randomized.
Participant milestones
| Measure |
Pharmacist-Bidirectional Texting Group
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
211
|
|
Overall Study
COMPLETED
|
209
|
211
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Body mass index (BMI) missing for 4 participants in Intervention group and 8 participants in the Control group.
Baseline characteristics by cohort
| Measure |
Pharmacist-Bidirectional Texting Group
n=209 Participants
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
n=211 Participants
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 13.7 • n=209 Participants
|
58.4 Years
STANDARD_DEVIATION 13.6 • n=211 Participants
|
58.6 Years
STANDARD_DEVIATION 13.6 • n=420 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=209 Participants
|
113 Participants
n=211 Participants
|
209 Participants
n=420 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=209 Participants
|
98 Participants
n=211 Participants
|
211 Participants
n=420 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=209 Participants
|
48 Participants
n=211 Participants
|
97 Participants
n=420 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=209 Participants
|
162 Participants
n=211 Participants
|
322 Participants
n=420 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=209 Participants
|
1 Participants
n=211 Participants
|
1 Participants
n=420 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=209 Participants
|
1 Participants
n=211 Participants
|
2 Participants
n=420 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=209 Participants
|
0 Participants
n=211 Participants
|
3 Participants
n=420 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=209 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=420 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=209 Participants
|
5 Participants
n=211 Participants
|
16 Participants
n=420 Participants
|
|
Race (NIH/OMB)
White
|
184 Participants
n=209 Participants
|
196 Participants
n=211 Participants
|
380 Participants
n=420 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=209 Participants
|
0 Participants
n=211 Participants
|
3 Participants
n=420 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=209 Participants
|
9 Participants
n=211 Participants
|
16 Participants
n=420 Participants
|
|
Body Mass Index
|
32.6 kg/m^2
STANDARD_DEVIATION 7.4 • n=209 Participants • Body mass index (BMI) missing for 4 participants in Intervention group and 8 participants in the Control group.
|
33.7 kg/m^2
STANDARD_DEVIATION 7.8 • n=211 Participants • Body mass index (BMI) missing for 4 participants in Intervention group and 8 participants in the Control group.
|
33.1 kg/m^2
STANDARD_DEVIATION 7.7 • n=420 Participants • Body mass index (BMI) missing for 4 participants in Intervention group and 8 participants in the Control group.
|
|
Level of Education
< High School
|
32 Participants
n=209 Participants
|
46 Participants
n=211 Participants
|
78 Participants
n=420 Participants
|
|
Level of Education
High School
|
66 Participants
n=209 Participants
|
56 Participants
n=211 Participants
|
122 Participants
n=420 Participants
|
|
Level of Education
Some College
|
37 Participants
n=209 Participants
|
46 Participants
n=211 Participants
|
83 Participants
n=420 Participants
|
|
Level of Education
Associate's Degree
|
27 Participants
n=209 Participants
|
20 Participants
n=211 Participants
|
47 Participants
n=420 Participants
|
|
Level of Education
Bachelor's Degree
|
30 Participants
n=209 Participants
|
24 Participants
n=211 Participants
|
54 Participants
n=420 Participants
|
|
Level of Education
Master's Degree
|
10 Participants
n=209 Participants
|
10 Participants
n=211 Participants
|
20 Participants
n=420 Participants
|
|
Level of Education
Doctoral Degree
|
5 Participants
n=209 Participants
|
6 Participants
n=211 Participants
|
11 Participants
n=420 Participants
|
|
Level of Education
Trade School
|
2 Participants
n=209 Participants
|
3 Participants
n=211 Participants
|
5 Participants
n=420 Participants
|
|
Smoking History
Never Smoked
|
117 Participants
n=209 Participants
|
120 Participants
n=211 Participants
|
237 Participants
n=420 Participants
|
|
Smoking History
Current Smoker
|
37 Participants
n=209 Participants
|
34 Participants
n=211 Participants
|
71 Participants
n=420 Participants
|
|
Smoking History
Former Smoker
|
55 Participants
n=209 Participants
|
57 Participants
n=211 Participants
|
112 Participants
n=420 Participants
|
|
Baseline Systolic Blood Pressure
|
156.0 mmHg
STANDARD_DEVIATION 13.7 • n=209 Participants
|
153.4 mmHg
STANDARD_DEVIATION 14.0 • n=211 Participants
|
154.3 mmHg
STANDARD_DEVIATION 14.0 • n=420 Participants
|
|
Baseline Diastolic Blood Pressure
|
88.4 mmHg
STANDARD_DEVIATION 12.3 • n=209 Participants
|
90.1 mmHg
STANDARD_DEVIATION 12.5 • n=211 Participants
|
89.5 mmHg
STANDARD_DEVIATION 11.9 • n=420 Participants
|
|
10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk
|
17.3 Percentage
STANDARD_DEVIATION 14.2 • n=89 Participants • Many variables are required to calculate an ASCVD Risk Score. If any variables are missing, the score cannot be calculated.
|
15.0 Percentage
STANDARD_DEVIATION 14.7 • n=109 Participants • Many variables are required to calculate an ASCVD Risk Score. If any variables are missing, the score cannot be calculated.
|
16.0 Percentage
STANDARD_DEVIATION 14.5 • n=198 Participants • Many variables are required to calculate an ASCVD Risk Score. If any variables are missing, the score cannot be calculated.
|
|
Medical History
Angina
|
22 participants
n=209 Participants
|
8 participants
n=211 Participants
|
30 participants
n=420 Participants
|
|
Medical History
Chronic Kidney Disease
|
13 participants
n=209 Participants
|
11 participants
n=211 Participants
|
24 participants
n=420 Participants
|
|
Medical History
Coronary Artery Disease
|
18 participants
n=209 Participants
|
12 participants
n=211 Participants
|
30 participants
n=420 Participants
|
|
Medical History
Diabetes Mellitus
|
57 participants
n=209 Participants
|
65 participants
n=211 Participants
|
122 participants
n=420 Participants
|
|
Medical History
Heart Failure
|
10 participants
n=209 Participants
|
6 participants
n=211 Participants
|
16 participants
n=420 Participants
|
|
Medical History
Hyperlipidemia
|
60 participants
n=209 Participants
|
53 participants
n=211 Participants
|
113 participants
n=420 Participants
|
|
Medical History
Heart Attack
|
10 participants
n=209 Participants
|
4 participants
n=211 Participants
|
14 participants
n=420 Participants
|
|
Medical History
Stroke
|
11 participants
n=209 Participants
|
5 participants
n=211 Participants
|
16 participants
n=420 Participants
|
|
Medical History
Transient Ischemic Attack (TIA)
|
1 participants
n=209 Participants
|
2 participants
n=211 Participants
|
3 participants
n=420 Participants
|
|
Hypertension Medications
|
1.7 medications
STANDARD_DEVIATION 1.2 • n=209 Participants
|
1.5 medications
STANDARD_DEVIATION 1.3 • n=211 Participants
|
1.6 medications
STANDARD_DEVIATION 1.2 • n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 4
|
35 Participants
n=209 Participants
|
44 Participants
n=211 Participants
|
79 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 5
|
21 Participants
n=209 Participants
|
15 Participants
n=211 Participants
|
36 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 6
|
1 Participants
n=209 Participants
|
0 Participants
n=211 Participants
|
1 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 7
|
80 Participants
n=209 Participants
|
73 Participants
n=211 Participants
|
153 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 8
|
5 Participants
n=209 Participants
|
2 Participants
n=211 Participants
|
7 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 9
|
3 Participants
n=209 Participants
|
5 Participants
n=211 Participants
|
8 Participants
n=420 Participants
|
|
Rural-Urban Commuting Area Codes
RUCA 10
|
64 Participants
n=209 Participants
|
72 Participants
n=211 Participants
|
136 Participants
n=420 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Blood pressure was measured by the research team at baseline, 6 months, and 12 months. All participants had a baseline measurement. Some were missing 6- or 12-month measurements. All collected measurements were included in the model estimation.
The difference between the groups in the change from baseline to 12 months in systolic blood pressure in mm Hg.
Outcome measures
| Measure |
Pharmacist-Bidirectional Texting Group
n=494 BP Measurements
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
n=511 BP Measurements
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
|---|---|---|
|
Difference in Change in Systolic Blood Pressure- 12 Months
|
-23.8 mmHg
Standard Deviation 19.4
|
-19.6 mmHg
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Blood pressure was measured by the research team at baseline, 6 months, and 12 months. All participants had a baseline measurement. Some were missing 6- or 12-month measurements. All collected measurements were included in the model estimation.
The difference between the groups in the change from baseline to 12 months in diastolic blood pressure in mmHg.
Outcome measures
| Measure |
Pharmacist-Bidirectional Texting Group
n=494 BP Measurements
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
n=511 BP Measurements
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
|---|---|---|
|
Difference in Change in Diastolic Blood Pressure- 12 Months
|
-9.1 mmHg
Standard Deviation 13.4
|
-9.6 mmHg
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants had a BP medication chart review at baseline, 6 months, and 12 months unless they withdrew from the study prior to a chart review period.
Total number of medication changes (i.e., dose, discontinuation, initiation, etc.) from 6 months to 12 months as documented in the medical record.
Outcome measures
| Measure |
Pharmacist-Bidirectional Texting Group
n=392 Medication Chart Reviews
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
n=405 Medication Chart Reviews
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
|---|---|---|
|
Number of Medication Changes From 6 to 12 Months
|
0.59 Medication Changes
Standard Deviation 0.98
|
0.44 Medication Changes
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 12 monthsTotal cost of medications, time spent by research staff, and clinics visits per patient from baseline.
Outcome measures
| Measure |
Pharmacist-Bidirectional Texting Group
n=209 Participants
Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.
Experimental: Pharmacist-Bidirectional Texting Group: The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
|
Control Group
n=211 Participants
Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.
Active Comparator: Control Group: This group will receive bidirectional texting, but no pharmacist monitoring.
|
|---|---|---|
|
Dollars Spent Per Patient for 12 Month Bidirectional Texting/Pharmacist Intervention
|
980.17 Dollars
Standard Deviation 1127.91
|
838.95 Dollars
Standard Deviation 713.45
|
Adverse Events
Pharmacist-Bidirectional Texting Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place