Written Behavioural Persuasion Technique Intervention for Hypertension Management

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966597
• Other study ID #: MUHREC38735
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Monash University Malaysia
• Contact: Chiew Way Ang
• Phone: +6079310240
• Email: ang.chiewway[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 830
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Malaysia	South East Asia Community Observatory, Monash University Malaysia	Segamat	Johor

Sponsors (2)

Lead Sponsor	Collaborator
Monash University Malaysia	Monash University

Country where clinical trial is conducted

Malaysia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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