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Clinical Trials/NCT04565548
NCT04565548
Unknown
Not Applicable

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

The Hong Kong Polytechnic University2 sites in 2 countries148 target enrollmentMarch 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension,Essential
Sponsor
The Hong Kong Polytechnic University
Enrollment
148
Locations
2
Primary Endpoint
Change of blood pressure at week 8 and week 12
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2021
End Date
September 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Renal hypertension
  • Mini-Cog \< 3

Outcomes

Primary Outcomes

Change of blood pressure at week 8 and week 12

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

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