NCT04565548

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 4, 2021

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 10, 2020

Last Update Submit

August 2, 2021

Conditions

Hypertension,Essential

Keywords

hypertensionadherenceself-efficacyeducational intervention

Outcome Measures

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.

    Baseline, week 8, week 12

Secondary Outcomes (2)

  • Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12

    Baseline, week 8, week 12

  • Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12

    Baseline, week 8, week 12

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Educational program for hypertensive patients

Control

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Educational program for hypertensive patientsOTHER

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

Intervention
Usual careOTHER

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.

Control

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Renal hypertension
  • Mini-Cog \< 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37295501DERIVED

MeSH Terms

Conditions

Essential HypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eliza Mi Ling Wong, Dr

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Lon Tam, MSc

CONTACT

(852) 3400 3804hon-lon.tam@connect.polyu.hk

Eliza Mi Ling Wong, Dr

CONTACT

(852) 2766 6544eliza.wong@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will not participate in group allocation or intervention delivery.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 25, 2020

Study Start

March 6, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

August 4, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)HK(1)