Clinical trial NCT05966597: Written Behavioural Persuasion Technique Intervention for Hypertension Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Behavior and Behavior Mechanisms
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2023-07-28
Enrollment: 893
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who see a doctor because of high blood pressure
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
measure: Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
measure: Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
measure: 12-item Health Literacy score
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
Secondary outcomes:
measure: Time taken for clinic visit (week)
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
measure: Blood pressure status during clinic visit
timeFrame: Follow-up after 4-6 weeks receiving the leaflet
Other outcomes:
Locations:
city: Segamat
country: Malaysia
facility: South East Asia Community Observatory, Monash University Malaysia
state: Johor
Study officials:
affiliation: Monash University Malaysia
name: Tin Tin Su
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.