Written Behavioural Persuasion Technique Intervention for Hypertension Management

Effectiveness of Written Behavioural Persuasion Technique Intervention for Hypertension Management Among The Untreated Hypertension Population of The Community Observatory in Segamat, Johor: a 2-arm Randomised Controlled Trial Within Cohort

This study aims to examine the feasibility and effectiveness of written behavioural persuasion techniques intervention to encourage treatment initiation and follow-up for hypertension management among the untreated hypertension population of the SEACO cohort.

Study Overview

• Status: Completed
• Conditions: Hypertension; Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: Written persuasive leaflet; Behavioral: Standard referral leaflet

Detailed Description

Each household is given a unique identifier called house_id in the SEACO database. The randomisation will be computer-generated according to their house_id with a ratio of 1:1. During the house visit, participants' blood pressure will be taken three times, and the final reading will be the average of the second and third readings. Participants will be assessed based on the inclusion and exclusion criteria, i.e., age 35 years and above, blood pressure reading and reported not being diagnosed with or treated for hypertension. At the end of the house visit, all participants will receive a standard referral leaflet, and participants randomised to the intervention group will receive an additional written behavioural persuasion leaflet.

• Study Type: Interventional
• Enrollment (Actual): 893
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Johor
    • Segamat, Johor, Malaysia, 85000
      • South East Asia Community Observatory, Monash University Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 35 and above
• Systolic blood pressure equal to or more than 140 mmHg
• Diastolic blood pressure equal to or more than 90 mmHg
• reported not being diagnosed with hypertension OR not being treated for hypertension

Exclusion Criteria:

• Involve in other research projects
• decline to participate/reject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written persuasive leaflet; Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.	Behavioral: Written persuasive leaflet; Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.; Behavioral: Standard referral leaflet; Standard referral leaflet provided at the end of the home-based health screening.
Sham Comparator: Standard referral leaflet; Participants will receive a standard referral leaflet.	Behavioral: Standard referral leaflet; Standard referral leaflet provided at the end of the home-based health screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who see a doctor because of high blood pressure	The number of participants who see a doctor because of high blood pressure	Follow-up after 4-6 weeks receiving the leaflet
Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)	6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' intention to go see the doctor about their blood pressure - "I intend to go to the doctor about my blood pressure", "I plan to go to the doctor about my blood pressure", "I want to go to the doctor about my blood pressure")	Follow-up after 4-6 weeks receiving the leaflet
Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)	6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' awareness of receiving the leaflets during the health visit and their perceptions of the leaflets' content, usefulness, impact on seeking medical attention, and aesthetic appeal - "The leaflets contain useful information", "The leaflet was helpful. It made it easier for me to see a doctor and manage my blood pressure/ It would make it easier for me to see a doctor and manage my blood pressure", "The leaflet was persuasive. It made me want to see a doctor for my blood pressure", "I like the colour and design of the leaflet".	Follow-up after 4-6 weeks receiving the leaflet
12-item Health Literacy score	12-item Health Literacy is a validated, self-reported instrument used to measure health literacy (HL). The index value for HL is obtained where 0 represents the lowest HL and 50 the highest HL	Follow-up after 4-6 weeks receiving the leaflet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken for clinic visit (week)	Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet	Follow-up after 4-6 weeks receiving the leaflet
Blood pressure status during clinic visit	Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)	Follow-up after 4-6 weeks receiving the leaflet

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback on the intervention leaflet	Participants in the intervention group will be asked if they remember receiving the intervention leaflet and if they find the leaflet useful to motivate them to go to the doctor for their high blood pressure. One open-ended question is added to ask which aspect of the intervention leaflet encourages them to see the doctor for high blood pressure.	Follow-up after 4 weeks of receiving the leaflet

Collaborators and Investigators

• Sponsor: Monash University Malaysia
• Collaborators: Monash University
• Investigators: Principal Investigator: Tin Tin Su, Monash University Malaysia

Publications and helpful links

General Publications

• Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: MUHREC38735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available. The MUHREC requirement to comply with the term "Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years".

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No