Hypertension Treatment Adherence Improving Trial

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565548
• Other study ID #: HSEARS20200821002
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2021
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: The Hong Kong Polytechnic University
• Contact: Hon Lon Tam, MSc
• Phone: (852) 3400 3804
• Email: hon-lon.tam[@]connect.polyu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Other:
• Educational program for hypertensive patients
The theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks.
• Usual care
One standardized health education and a leaflet developed by the Health Bureau. As similar as the intervention group, weekly text messaging will be delivered, but the content is not related to the blood pressure control.

Locations

Country	Name	City	State
China	Community Health Centres	Shenzhen	Shenzhen
Hong Kong	Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of blood pressure at week 8 and 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.	Baseline, week 8, week 12
Secondary	Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12	TAQPH consists of 28 items and covers the adherence to medications and lifestyle modifications in hypertension management. The responses are made on a 1-4 scale, and the sum of the score ranges from 28 to 112. The TAQPH has been proved to be reliable with good Cronbach's alpha coefficient 0.86 for Chinese hypertensive adults.	Baseline, week 8, week 12
Secondary	Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12	SEMCD consists of six self-report items to measure the self-efficacy of hypertension management. Summative scores range from 6 to 60. The scale was translated into Chinese and yielded a good reliability (Cronbach's alpha = 0.88-0.98; teste-retest reliability = 0.73-0.98) in Chinese hypertensive adults and Chinese older adults.	Baseline, week 8, week 12