Hypertension Treatment Adherence Improving Trial

August 2, 2021 updated by: The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shenzhen
      • Shenzhen, Shenzhen, China, 00
        • Not yet recruiting
        • Community Health Centres
        • Contact:
  • Hong Kong
      • Kowloon, Hong Kong
        • Recruiting
        • Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau
        • Contact:
          • Raven Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will receive the newly developed theory-guided program for 12 weeks.
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.
Active Comparator: Control
Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 8, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
Time Frame: Baseline, week 8, 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
Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
Time Frame: Baseline, week 8, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Eliza Mi Ling Wong, Dr, Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20200821002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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