CClinicalTrials.gg
Status unknownNCT04565548Updated Aug 4, 2021

Hypertension Treatment Adherence Improving Trial

An interventional study of Educational program for hypertensive patients and Usual care in Hypertension,Essential, sponsored by The Hong Kong Polytechnic University. Status unknown at 2 sites in 2 countries. Open to participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-08-04.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
45 Years to 74 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension,Essential

Keywords

  • hypertension
  • adherence
  • self-efficacy
  • educational intervention
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 148 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Renal hypertension
  • Mini-Cog \< 3
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    Intervention

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

    Other: Educational program for hypertensive patients

  • Active comparator
    Control

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

    Other: Usual care

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, week 8, week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline, week 8, week 12

  2. 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.

    Time frame: Baseline, week 8, week 12

07

Study locations

1 of 2 sites recruiting
  • Community Health Centres
    Shenzhen, Shenzhen 00, China
    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
    • Raven Lee · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04565548
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Mar 6, 2021
Primary completion
Sep 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Aug 4, 2021

Study contacts

Hon Lon Tam, MSc
Contact
hon-lon.tam@connect.polyu.hk
(852) 3400 3804
Eliza Mi Ling Wong, Dr
Contact
eliza.wong@polyu.edu.hk
(852) 2766 6544
Eliza Mi Ling Wong, Dr
principal investigator · Hong Kong Polytechnic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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