Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension at a General Medicine Outpatient Clinic in a Tertiary Center in Manila, Philippines: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Mean Absolute Change in Systolic Blood Pressure After 12 Weeks
Study Overview
Brief Summary
Objective: To test the primary hypothesis that SMS text messages delivered to patients via mobile phone can improve blood pressure within 12 weeks compared to usual care
Design: Parallel group, randomized, controlled trial; the patient is the unit of randomization
Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and Private Outpatient Clinics near the Philippine General Hospital
Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of essential hypertension, on maintenance blood pressure-lowering medications, who have daily access to a mobile phone in the household and know or live with someone who knows how to retrieve, read and reply to text messages using a mobile phone
Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide information regarding hypertension; 2) remind patients to take their medications.
Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood pressure control rate and medication adherence.
Detailed Description
The study will be done in 2 phases:
Phase I: Development of the SMS text messages
The SMS messages to be used in the trial will be developed and pre-tested in focus group discussions of a convenience sample of subjects similar to the target population for understandability and acceptability.
Phase II: Parallel group, open-label, randomized, controlled trial
Target Population
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ambulatory adult patients of both sexes with age at least 19 years old being seen at the General Medicine Outpatient Clinic of the Philippine General Hospital
- •A diagnosis of hypertension in the medical record
- •On at least 1 maintenance medication for hypertension for at least 1 month
- •A systolic blood pressure greater than 129 mmHg and less than 160 mmHg or a diastolic blood pressure greater than 79 mmHg or less than 100 mmHg at the time of screening
- •Patients with daily access to a mobile phone in the household
- •Patients who live with someone who knows how to retrieve and read text messages on their mobile phone, and can relay these messages to them
- •Written informed consent
Exclusion Criteria
- •Participation in other studies within one month of trial initiation
- •Patients who are unable or refuse to give informed consent
- •Patients who have a clinical condition that might interfere with the study (dementia, psychological disorder)
- •Patients who share a household with another patient who has already been recruited to participate in this study
Arms & Interventions
SMS text reminders
Participants in this arm will receive SMS text messages on top of the usual care they receive from their physicians.
Intervention: SMS text reminders (Other)
Usual Care
Participants in this arm will receive the usual care they receive from their physicians.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Mean Absolute Change in Systolic Blood Pressure After 12 Weeks
Time Frame: baseline and 12 weeks
Absolute change in systolic blood pressure from baseline to 12 weeks
Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks
Time Frame: baseline and 12 weeks
Absolute change in diastolic blood pressure from baseline to 12 weeks
Secondary Outcomes
- Medication Adherence Rate(12 weeks)
- Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks(12 weeks)
Investigators
Lia M. Palileo
Clinical Associate Professor
University of the Philippines