Written Behavioural Persuasion Technique Intervention for Hypertension Management

• Sponsor: Monash University Malaysia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05966597
• Collaborator: Monash University (Other)
• Enrollment: 830
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Behavior and Behavior Mechanisms	Behavioral: Written persuasive leaflet; Behavioral: Standard referral leaflet	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 830 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Written persuasive leaflet Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.	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.; Behavioral: Standard referral leaflet; Standard referral leaflet provided at the end of the home-based health screening.
Sham Comparator: Standard referral leaflet Participants will receive a standard referral leaflet.	Behavioral: Standard referral leaflet; Standard referral leaflet provided at the end of the home-based health screening.

Outcome Measures

Primary Outcome Measures

1. Number of participants who see a doctor because of high blood pressure at Week 4 [Follow-up after 4 weeks receiving the leaflet]

   The number of participants who see a doctor because of high blood pressure within 4

Secondary Outcome Measures

1. Time taken for clinic visit (week) [Follow-up after 4 weeks of 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 [Follow-up after 4 weeks of receiving the leaflet]

   Participants' self-reported blood pressure status during the visit to the clinic/doctor.

3. 12-item Health Literacy score [Follow-up after 4 weeks of 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

Other Outcome Measures

1. Feedback on the intervention leaflet [Follow-up after 4 weeks of receiving the leaflet]

   Participants in the intervention group will be asked if they remember receiving the intervention leaflet and if they find the leaflet useful to motivate them to go to the doctor for their high blood pressure. One open-ended question is added to ask which aspect of the intervention leaflet encourages them to see the doctor for high blood pressure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: 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:

• Involve in other research projects

• decline to participate/reject

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Monash University Malaysia
• Monash University

Investigators

• Principal Investigator: Tin Tin Su, Monash University Malaysia

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Tin Tin Su, Director of SEACO & Professor Global Public Health, Monash University Malaysia
• ClinicalTrials.gov Identifier: NCT05966597
• Other Study ID Numbers: MUHREC38735
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 28, 2023