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

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05711004
Collaborator
(none)
200
2
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education via SMS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible participants with uncontrolled HTN will be randomly assigned to experiment (SMS) or control (routine care) groups at a 1:1 ratio.Eligible participants with uncontrolled HTN will be randomly assigned to experiment (SMS) or control (routine care) groups at a 1:1 ratio.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Education Via Phone-based Text Messaging (SMS) on Patients With Uncontrolled Hypertension: a Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SMS group

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
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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [Three months after the start of intervention]

    Systolic and diastolic blood pressure

Secondary Outcome Measures

  1. Medication adherence which will be assessed by Morisky Medication Adherence Scale [Three months after the start of intervention]

    Adherence to the anti-HTN drugs will be assessed by Morisky Medication Adherence Scale .

  2. Practice according to the KAP questionnaire [Three months after the start of intervention]

    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.

  3. Weight [Three months after the start of intervention]

    Body weight (kg)

  4. Number of patients who think that messages were usefull and had positive impact [Three months after the start of intervention]

    Acceptability of the messages will be assessed according to the questiones listed in doi: 10.5334/gh.1103

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Reza Safarpour, Manager in chief of gastroenterohepatology research center, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05711004
Other Study ID Numbers:
  • 27586
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023