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CompletedNCT05966597Updated May 9, 2025

Written Behavioural Persuasion Technique Intervention for Hypertension Management

An interventional study of Written persuasive leaflet and Standard referral leaflet in Hypertension and Behavior and Behavior Mechanisms, sponsored by Monash University Malaysia. Completed at 1 site in Malaysia. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by Monash University Malaysia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
893
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Hypertension
  • Behavior and Behavior Mechanisms

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 893 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Monash University Malaysia is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
893 participants (actual)

Study arms

  • Experimental
    Written persuasive leaflet

    Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.

    Behavioral: Written persuasive leaflet · Behavioral: Standard referral leaflet

  • Sham comparator
    Standard referral leaflet

    Participants will receive a standard referral leaflet.

    Behavioral: Standard referral leaflet

Interventions

  • BehavioralWritten persuasive leaflet

    Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.

  • BehavioralStandard referral leaflet

    Standard referral leaflet provided at the end of the home-based health screening.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

  2. 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")

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

  3. 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".

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

  4. 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

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

Secondary outcomes

  1. 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

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

  2. Blood pressure status during clinic visit

    Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)

    Time frame: Follow-up after 4-6 weeks receiving the leaflet

07

Study locations

1 site
  • South East Asia Community Observatory, Monash University Malaysia
    Segamat, Johor 85000, Malaysia
08

References and documents

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. PubMed 31294310 ↗

Individual participant data

Plan to share: No — 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".

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05966597
Lead sponsor
Monash University Malaysia
Collaborators
Monash University
Responsible party
Tin Tin Su (Director of SEACO & Professor Global Public Health, Monash University Malaysia) — Principal investigator
First posted
Jul 28, 2023
Start date
Sep 14, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
May 9, 2025

Study contacts

Tin Tin Su
principal investigator · Monash University Malaysia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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