Efficacy of Education Via Phone-based Text Messaging (SMS) on Patients With Uncontrolled Hypertension

Study Overview
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Brief Summary
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Uncontrolled hypertension (HTN) is a major public health worldwide, which increases the risk of cardiovascular diseases. Low adherence to medication, unhealthy lifestyle and poor knowledge of HTN diagnosis and treatment are among the known factors associated with uncontrolled HTN. Digital innovations became popular as low-cost tools to provide personalized advice to people with long-term health conditions, leading to their adherence to health behavior modifications. Therefore, this randomized single-blind controlled trial (RCT) aimed to test whether providing health information via a short message service (SMS) influences blood pressure control, health practice, and medication adherence. For the current RCT, the investigators will use data from the PERSIAN Kavar cohort study (PKCS). Eligible participants with uncontrolled HTN will be randomly assigned to experiment (SMS) or control (routine care) groups at a 1:1 ratio. Participants in the experimental group will receive three messages/per week for three months. Systolic and diastolic blood pressure will be the primary outcomes of this study. Medication adherence and practice related to cardiovascular diseases will the secondary outcomes. These variables will be assessed before and after the intervention. At the end of the study, the acceptability of the messages will also be assessed.

Official Title
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Efficacy of Education Via Phone-based Text Messaging (SMS) on Patients With Uncontrolled Hypertension: a Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Education via SMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have a diagnosis of HTN by a clinician at the baseline or until the third follow-up of PKCS, have uncontrolled HTN (≥140/90) at the enrollment, have a prescription for blood pressure-lowering medication, understand Persian, have regular access to a mobile phone, and are able to read SMS by themselves or with their family's help. The investigators will enroll only one member per household. Exclusion Criteria: Those with renal failure or requiring specialist care for their hypertension at a hospital, pregnant women or who are within 3 months postpartum, patients with severe physical or mental illness, and subjects not willing to participate in the study.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible participants with uncontrolled HTN will be randomly assigned to experiment (SMS) or control (routine care) groups at a 1:1 ratio.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS group<br>Participants in the experimental group will receive three messages per week in the morning (9-10 am) for three months. The investigators will call them every month to ensure that the SMS is delivered. | Behavioral: Education via SMS<br>* Participants in the experimental group will receive three messages per week in the morning (9-10 am) for three months. The investigators will call them every month to ensure that the SMS is delivered.<br>|
| No Intervention: Control group<br>Patients in the control group will also receive the usual primary health care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure | Three months after the start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence which will be assessed by Morisky Medication Adherence Scale | Adherence to the anti-HTN drugs will be assessed by Morisky Medication Adherence Scale . | Three months after the start of intervention | 
| Practice according to the KAP questionnaire | The questions of Knowledge, Attitude, and Practice Regarding Cardiovascular Diseases (doi: 10.5812/ijem.101612) questionnaire that are related to Practice will be completed for patients. | Three months after the start of intervention | 
| Weight | Body weight (kg) | Three months after the start of intervention | 
| Number of patients who think that messages were usefull and had positive impact | Acceptability of the messages will be assessed according to the questiones listed in doi: 10.5334/gh.1103 | Three months after the start of intervention |