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临床试验/NCT04565548
NCT04565548Unknown不适用

Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 2 个国家目标入组 148 人开始时间: 2021年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
148
试验地点
2
主要终点
Change of blood pressure at week 8 and week 12

研究概览

简要总结

Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. In this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform an effective way to conduct health promotion in community. The improved adherence to lifestyle modifications and medications will be beneficial to the clients' health.

详细描述

Persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. But low adherence to lifestyle modifications and medication were noted in reviews and studies. Low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. In this study, an educational program guided by the Health Promotion Model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. A 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health.

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
Single (Outcomes Assessor)

盲法说明

Outcomes assessors will not participate in group allocation or intervention delivery.

入排标准

年龄范围
45 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Own a mobile phone and able to use
  • •Able to communicate with Cantonese and read Chinese
  • •Diagnosed with hypertension and taking at least one anti-hypertensive medication
  • •SBP = 131~159 mmHg or DBP = 81~99 mmHg

排除标准

  • •Renal hypertension
  • •Mini-Cog < 3

研究组 & 干预措施

Intervention

Experimental

Participants will receive the newly developed theory-guided program for 12 weeks.

干预措施: Educational program for hypertensive patients (Other)

Control

Active Comparator

Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.

干预措施: Usual care (Other)

结局指标

主要结局

Change of blood pressure at week 8 and week 12

时间窗: Baseline, week 8, week 12

Systolic and diastolic blood pressure (mmHg) is measured by a trained research assistant. A validated upper-arm blood pressure monitor is used for the blood pressure measurement.

次要结局

  • Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12(Baseline, week 8, week 12)
  • Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12(Baseline, week 8, week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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