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Written Behavioural Persuasion Technique Intervention for Hypertension Management

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

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 14, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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")

  3. 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".

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05966597


Contacts
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Contact: Chiew Way Ang +6079310240 ang.chiewway@monash.edu
Contact: Hanoor Syahirah Zahari +60197159359 hanoor.zahari@monash.edu

Locations
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Malaysia
South East Asia Community Observatory, Monash University Malaysia Recruiting
Segamat, Johor, Malaysia, 85000
Contact: Chiew Way Ang    +6079310240    ang.chiewway@monash.edu   
Sponsors and Collaborators
Monash University Malaysia
Monash University
Investigators
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Principal Investigator: Tin Tin Su Monash University Malaysia
More Information
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Publications:

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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: July 28, 2023    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Individual Participant Data (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".

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases