Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- Change of blood pressure at week 8 and week 12
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessors will not participate in group allocation or intervention delivery.
Eligibility Criteria
- Ages
- 45 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
Participants will receive the newly developed theory-guided program for 12 weeks.
Intervention: Educational program for hypertensive patients (Other)
Control
Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.
Intervention: Usual care (Other)
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)