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临床试验/NCT05966597
NCT05966597已完成不适用

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

Monash University Malaysia1 个研究点 分布在 1 个国家目标入组 893 人开始时间: 2023年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
893
试验地点
1
主要终点
Number of participants who see a doctor because of high blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Involve in other research projects
  • •decline to participate/reject

研究组 & 干预措施

Written persuasive leaflet

Experimental

Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.

干预措施: Written persuasive leaflet (Behavioral)

Written persuasive leaflet

Experimental

Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.

干预措施: Standard referral leaflet (Behavioral)

Standard referral leaflet

Sham Comparator

Participants will receive a standard referral leaflet.

干预措施: Standard referral leaflet (Behavioral)

结局指标

主要结局

Number of participants who see a doctor because of high blood pressure

时间窗: Follow-up after 4-6 weeks receiving the leaflet

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

Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)

时间窗: 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

时间窗: 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

Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)

时间窗: 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")

次要结局

  • Blood pressure status during clinic visit(Follow-up after 4-6 weeks receiving the leaflet)
  • Time taken for clinic visit (week)(Follow-up after 4-6 weeks receiving the leaflet)

研究者

发起方
Monash University Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tin Tin Su

Director of SEACO & Professor Global Public Health

Monash University Malaysia

研究点 (1)

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