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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05711004
• Other study ID #: 27586
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2023
• Source: Shiraz University of Medical Sciences
• Contact: Ali Reza Safarpour, Ph.D.
• Phone: +98-7136281442
• Email: safarpourar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Education via SMS
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Systolic and diastolic blood pressure	Three months after the start of intervention
Secondary	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
Secondary	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
Secondary	Weight	Body weight (kg)	Three months after the start of intervention
Secondary	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