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

NCT05711004 | Unknown

• 1 other identifier: 27586
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Systolic and diastolic blood pressure

  Three months after the start of intervention

Secondary Outcomes (4)

• Medication adherence which will be assessed by Morisky Medication Adherence Scale

  Three months after the start of intervention

• Practice according to the KAP questionnaire

  Three months after the start of intervention

• Weight

  Three months after the start of intervention

• Number of patients who think that messages were usefull and had positive impact

  Three months after the start of intervention

Study Arms (2)

SMS group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the control group will also receive the usual primary health care.

Interventions

Education via SMS BEHAVIORAL

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.

SMS group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ali Reza Safarpour, Ph.D.

CONTACT

+98-7136281442; safarpourar@gmail.com

Sara Shojaei-Zarghani, Ph.D.

CONTACT

shojaeisara@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager in chief of gastroenterohepatology research center

Model Details: Eligible participants with uncontrolled HTN will be randomly assigned to experiment (SMS) or control (routine care) groups at a 1:1 ratio.

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: February 2, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01