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

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ClinicalTrials.gov Identifier: NCT01255436
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : October 2, 2012
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Department of Health, Philippines
Information provided by (Responsible Party):
Lia M. Palileo, University of the Philippines

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Other: SMS text reminders
Other: Usual Care
Enrollment 700
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description 2 SMS text reminders per week for 12 weeks Usual care consisting of clinic visits, physician advice and medication prescriptions
Period Title: Overall Study
Started 333 [1] 329 [2]
Completed 151 135
Not Completed 182 194
Reason Not Completed
Lost to Follow-up             178             191
Death, stroke, or MI             4             3
[1]
350 patients enrolled but 17 excluded because of missing baseline data.
[2]
350 patients enrolled but 21 excluded because of missing baseline data
Arm/Group Title SMS Text Reminders No SMS Text Reminders Total
Hide Arm/Group Description 2 SMS text reminders per week for 12 weeks Usual care consisting of clinic visits, physician advice and medication prescriptions Total of all reporting groups
Overall Number of Baseline Participants 333 329 662
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants 329 participants 662 participants
59.0  (10.7) 59.6  (11.1) 59.3  (10.9)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 329 participants 662 participants
Female
220
  66.1%
212
  64.4%
432
  65.3%
Male
113
  33.9%
117
  35.6%
230
  34.7%
Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 329 participants 662 participants
Unemployed 242 238 480
Employed 70 65 135
Retired 21 26 47
Educational Attainment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 329 participants 662 participants
No formal education 0 2 2
Elementary 84 79 163
High school 145 152 297
College 89 82 171
Other 15 14 29
Time in years since diagnosis of hypertension  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants 329 participants 662 participants
8.5  (11.1) 8.6  (8.2) 8.5  (10.4)
Number of prescribed drugs for hypertension  
Median (Full Range)
Unit of measure:  Medications
Number Analyzed 333 participants 329 participants 662 participants
2
(1 to 5)
2
(1 to 4)
2
(1 to 5)
Number of prescribed maintenance medications  
Median (Full Range)
Unit of measure:  Medications
Number Analyzed 333 participants 329 participants 662 participants
3
(1 to 10)
4
(1 to 13)
4
(1 to 13)
1.Primary Outcome
Title Mean Absolute Change in Systolic Blood Pressure After 12 Weeks
Hide Description Absolute change in systolic blood pressure from baseline to 12 weeks
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed follow up and had evaluable data were analyzed.
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description:
2 SMS text reminders per week for 12 weeks
Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Number of Participants Analyzed 151 135
Mean (Standard Deviation)
Unit of Measure: mmHg
-13.7  (19.1) -9.5  (25.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Text Reminders, No SMS Text Reminders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments p-value<0.05 is considered significant
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-9.4 to 1.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks
Hide Description Absolute change in diastolic blood pressure from baseline to 12 weeks
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who completed follow up and had evaluable data were analyzed.
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description:
2 SMS text reminders per week for 12 weeks
Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Number of Participants Analyzed 151 135
Mean (Standard Deviation)
Unit of Measure: mmHg
-6.2  (11.1) -4.7  (12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Text Reminders, No SMS Text Reminders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments p-value < 0.05 considered significant
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-4.1 to 1.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Medication Adherence Rate
Hide Description 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)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who completed follow up and had evaluable data were analyzed.
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description:
2 SMS text reminders per week for 12 weeks
Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Number of Participants Analyzed 151 135
Measure Type: Number
Unit of Measure: percentage of participants
59.6 47.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Text Reminders, No SMS Text Reminders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.0 to 1.6
Estimation Comments Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)
4.Secondary Outcome
Title Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who completed follow up and had evaluable data were analyzed.
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description:
2 SMS text reminders per week for 12 weeks
Usual care consisting of clinic visits, physician advice and medication prescriptions
Overall Number of Participants Analyzed 151 135
Measure Type: Number
Unit of Measure: percentage of participants
68.2 54.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Text Reminders, No SMS Text Reminders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.04 to 1.53
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SMS Text Reminders No SMS Text Reminders
Hide Arm/Group Description 2 SMS text reminders per week for 12 weeks Usual care consisting of clinic visits, physician advice and medication prescriptions
All-Cause Mortality
SMS Text Reminders No SMS Text Reminders
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SMS Text Reminders No SMS Text Reminders
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/333 (1.20%)      3/329 (0.91%)    
Cardiac disorders     
Myocardial Infarction  0/333 (0.00%)  0 1/329 (0.30%)  1
General disorders     
All-cause mortality [1]  3/333 (0.90%)  3 2/329 (0.61%)  2
Nervous system disorders     
Stroke  1/333 (0.30%)  1 0/329 (0.00%)  0
[1]
Cause of death unspecified.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SMS Text Reminders No SMS Text Reminders
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/333 (0.00%)      0/329 (0.00%)    
Strong conclusions cannot be made because of the high attrition rate at the end of the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Lia M. Palileo
Organization: University of the Philippines Manila
Phone: 6325679740
Responsible Party: Lia M. Palileo, University of the Philippines
ClinicalTrials.gov Identifier: NCT01255436     History of Changes
Other Study ID Numbers: GCS IM 2010-002 (R-006TE)
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: August 31, 2012
Results First Posted: October 2, 2012
Last Update Posted: February 23, 2017