Written Behavioural Persuasion Technique Intervention for Hypertension Management

• ClinicalTrials.gov Identifier: NCT05966597
• Recruitment Status: Recruiting
• First Posted: July 28, 2023
• Last Update Posted: January 23, 2024
• Sponsor: Monash University Malaysia
• Collaborator: Monash University
• Information provided by (Responsible Party): Tin Tin Su, Monash University Malaysia

Tracking Information

• First Submitted Date: July 20, 2023
• First Posted Date: July 28, 2023
• Last Update Posted Date: January 23, 2024
• Actual Study Start Date: September 14, 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 20, 2024)

• 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
• 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")
• 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".
• 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

Original Primary Outcome Measures (submitted: July 20, 2023)

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

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

Current Secondary Outcome Measures (submitted: January 20, 2024)

• 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
• 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)

Original Secondary Outcome Measures (submitted: July 20, 2023)

• Time taken for clinic visit (week) [ Time Frame: 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
• Blood pressure status during clinic visit [ Time Frame: Follow-up after 4 weeks of receiving the leaflet ]
  Participants' self-reported blood pressure status during the visit to the clinic/doctor.
• 12-item Health Literacy score [ Time Frame: 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

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: July 20, 2023)

Feedback on the intervention leaflet [ Time Frame: 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.

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Hypertension
• Behavior and Behavior Mechanisms

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

Study Arms

• Experimental: Written persuasive leaflet
  Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.
  Interventions:

  • Behavioral: Written persuasive leaflet
  • Behavioral: Standard referral leaflet
• Sham Comparator: Standard referral leaflet
  Participants will receive a standard referral leaflet.
  Intervention: Behavioral: Standard referral leaflet

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 20, 2023): 830
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Chiew Way Ang; +6079310240; ang.chiewway@monash.edu

Contact: Hanoor Syahirah Zahari; +60197159359; hanoor.zahari@monash.edu

• Listed Location Countries: Malaysia

Administrative Information

• NCT Number: NCT05966597
• Other Study ID Numbers: MUHREC38735
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: 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".

• Current Responsible Party: Tin Tin Su, Monash University Malaysia
• Original Responsible Party: Same as current
• Current Study Sponsor: Monash University Malaysia
• Original Study Sponsor: Same as current
• Collaborators: Monash University

Investigators

• Principal Investigator: Tin Tin Su; Monash University Malaysia

• PRS Account: Monash University Malaysia
• Verification Date: January 2024