NCT05966597

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
893

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

July 20, 2023

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Time taken for clinic visit (week)

    Follow-up after 4-6 weeks receiving the leaflet

  • Blood pressure status during clinic visit

    Follow-up after 4-6 weeks receiving the leaflet

Study Arms (2)

Written persuasive leaflet

EXPERIMENTAL

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

Behavioral: Written persuasive leafletBehavioral: Standard referral leaflet

Standard referral leaflet

SHAM COMPARATOR

Participants will receive a standard referral leaflet.

Behavioral: Standard referral leaflet

Interventions

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

Written persuasive leaflet

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

Standard referral leafletWritten persuasive leaflet

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South East Asia Community Observatory, Monash University Malaysia

Segamat, Johor, 85000, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 31294310BACKGROUND

MeSH Terms

Conditions

HypertensionBehavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tin Tin Su

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of SEACO & Professor Global Public Health

Study Record Dates

First Submitted

July 20, 2023

First Posted

July 28, 2023

Study Start

September 14, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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".

Locations