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Completed

NCT Number: NCT05966597

Written Behavioural Persuasion Technique Intervention for Hypertension Management

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.

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Key information

Conditions

Hypertension Behavior Behavior and Behavior Mechanisms Cardiovascular Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South East Asia Community Observatory, Monash University Malaysia

Segamat, Johor, 85000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written persuasive leaflet

Behavioral

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

Standard referral leaflet

Behavioral

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

Primary outcomes

  1. Number of participants who see a doctor because of high blood pressure

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

    The number of participants who see a doctor because of high blood pressure

  2. Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)

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

    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")

  3. Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)

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

    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".

  4. 12-item Health Literacy score

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

    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

Secondary outcomes

  1. Time taken for clinic visit (week)

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

    Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet

  2. Blood pressure status during clinic visit

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

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

Sponsors and collaborators

Lead sponsor

Monash University Malaysia

Other

Collaborators

  • Monash University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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