Written Behavioural Persuasion Technique Intervention for Hypertension Management
Primary Purpose
Hypertension, Behavior and Behavior Mechanisms
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Written persuasive leaflet
Standard referral leaflet
Sponsored by
About this trial
This is an interventional other trial for Hypertension
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
Sites / Locations
- South East Asia Community Observatory, Monash University MalaysiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Written persuasive leaflet
Standard referral leaflet
Arm Description
Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.
Participants will receive a standard referral leaflet.
Outcomes
Primary Outcome Measures
Number of participants who see a doctor because of high blood pressure at Week 4
The number of participants who see a doctor because of high blood pressure within 4
Secondary Outcome Measures
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
Blood pressure status during clinic visit
Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)
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
Full Information
NCT ID
NCT05966597
First Posted
July 20, 2023
Last Updated
September 19, 2023
Sponsor
Monash University Malaysia
Collaborators
Monash University
1. Study Identification
Unique Protocol Identification Number
NCT05966597
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University Malaysia
Collaborators
Monash University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Behavior and Behavior Mechanisms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
830 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Written persuasive leaflet
Arm Type
Experimental
Arm Description
Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.
Arm Title
Standard referral leaflet
Arm Type
Sham Comparator
Arm Description
Participants will receive a standard referral leaflet.
Intervention Type
Behavioral
Intervention Name(s)
Written persuasive leaflet
Intervention Description
Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.
Intervention Type
Behavioral
Intervention Name(s)
Standard referral leaflet
Intervention Description
Standard referral leaflet provided at the end of the home-based health screening.
Primary Outcome Measure Information:
Title
Number of participants who see a doctor because of high blood pressure at Week 4
Description
The number of participants who see a doctor because of high blood pressure within 4
Time Frame
Follow-up after 4 weeks receiving the leaflet
Secondary Outcome Measure Information:
Title
Time taken for clinic visit (week)
Description
Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet
Time Frame
Follow-up after 4 weeks of receiving the leaflet
Title
Blood pressure status during clinic visit
Description
Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)
Time Frame
Follow-up after 4 weeks of receiving the leaflet
Title
12-item Health Literacy score
Description
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
Time Frame
Follow-up after 4 weeks of receiving the leaflet
Other Pre-specified Outcome Measures:
Title
Feedback on the intervention leaflet
Description
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.
Time Frame
Follow-up after 4 weeks of receiving the leaflet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiew Way Ang
Phone
+6079310240
Email
ang.chiewway@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hanoor Syahirah Zahari
Phone
+60197159359
Email
hanoor.zahari@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tin Tin Su
Organizational Affiliation
Monash University Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
South East Asia Community Observatory, Monash University Malaysia
City
Segamat
State/Province
Johor
ZIP/Postal Code
85000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiew Way Ang
Phone
+6079310240
Email
ang.chiewway@monash.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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".
Citations:
PubMed Identifier
31294310
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.
Results Reference
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Written Behavioural Persuasion Technique Intervention for Hypertension Management
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