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Hypertension Treatment Adherence Improving Trial

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565548
Enrollment
148
Registered
2020-09-25
Start date
2021-03-06
Completion date
2021-09-30
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

hypertension, adherence, self-efficacy, educational intervention

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.

Interventions

OTHEREducational 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.

OTHERUsual 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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

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

Sex/Gender
ALL
Age
45 Years to 74 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change of blood pressure at week 8 and week 12Baseline, week 8, week 12Systolic 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

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

Countries

China, Hong Kong

Contacts

Primary ContactHon Lon Tam, MSc
hon-lon.tam@connect.polyu.hk(852) 3400 3804
Backup ContactEliza Mi Ling Wong, Dr
eliza.wong@polyu.edu.hk(852) 2766 6544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026