Hypertension Treatment Adherence Improving Trial

NCT ID: NCT04565548

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-06

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension,Essential

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors will not participate in group allocation or intervention delivery.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Participants will receive the newly developed theory-guided program for 12 weeks.

Group Type EXPERIMENTAL

Educational program for hypertensive patients

Intervention Type OTHER

The theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks.

Control

Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eliza Mi Ling Wong, Dr

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Community Health Centres

Shenzhen, Shenzhen, China

Site Status NOT_YET_RECRUITING

Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau

Kowloon, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hon Lon Tam, MSc

Role: CONTACT

(852) 3400 3804

Eliza Mi Ling Wong, Dr

Role: CONTACT

(852) 2766 6544

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Qun Wang, PhD

Role: primary

Raven Lee

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Tam HL, Wong EML, Cheung K. Educational Program with Text Messaging for Community-Dwelling Patients with Hypertension: A Pilot Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):158-166. doi: 10.1016/j.anr.2023.06.001. Epub 2023 Jun 7.

Reference Type DERIVED
PMID: 37295501 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSEARS20200821002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pill Bottle vs Reminder App
NCT06034301 COMPLETED NA
Mobile Health Management of Hypertension
NCT05856955 NOT_YET_RECRUITING NA