Clinical trial NCT04565548: Hypertension Treatment Adherence Improving Trial
Official title: Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension,Essential
Keywords: hypertension
adherence
self-efficacy
educational intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 148
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change of blood pressure at week 8 and week 12
timeFrame: Baseline, week 8, week 12
Secondary outcomes:
measure: Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
timeFrame: Baseline, week 8, week 12
measure: Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
timeFrame: Baseline, week 8, week 12
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Community Health Centres
state: Shenzhen
city: Kowloon
country: Hong Kong
facility: Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau
Study officials:
affiliation: Hong Kong Polytechnic University
name: Eliza Mi Ling Wong, Dr
role: PRINCIPAL_INVESTIGATOR
References: