Effects of a Health Literacy-tailored Self-management Intervention on People With Hypertension

Effects of a Health Literacy-tailored Self-management Intervention on Blood Pressure Levels Among People With Hypertension: A Randomised Controlled Trial

This project aims to investigate the effects of a health literacy-tailored self-management intervention among people with hypertension and low health literacy. The primary research question examines the impact of this intervention on blood pressure levels in this population.

Participants will take part in a 6-week intervention consisting of three onsite sessions and three telephone-based sessions, with one session delivered per week. Health literacy-tailored educational materials will be developed to support participants throughout the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension (HTN)
• Intervention / Treatment: Behavioral: health literacy-tailored self-management intervention

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nhi Thi Vo, PhD post-candidacy; Phone Number: (+852) 56257068; Email: vtnhi@link.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older
• Diagnosed with primary hypertension, blood pressure ≥ 140/90 mmHg and taking at least one anti-hypertensive drug
• Health literacy score of 33 or below
• Access to a smartphone
• Able to read and speak in Vietnamese language.

Exclusion Criteria:

• Pregnant women
• Patients with secondary hypertension, psychiatric disorders or cognitive impairments.
• Unable to answer telephone calls.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Behavioral: health literacy-tailored self-management intervention; The participants in the intervention group will receive usual care combine with three weekly face-to-face group sessions (1 hour/week, 6-8 participants) at community health centres, followed by three weekly individual phone call sessions (20 minutes/session).
No Intervention: Control group; The participants in the control group will receive care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure levels	Participants' blood pressure levels will be measured using a validated digital sphygmomanometer.	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving optimal blood pressure control	the number of participants with optimal blood pressure control at each measurement time point divided by the total number of patients enrolled in the group	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Medication adherence	The Vietnamese General Medication Adherence Scale (GMAS) will be used to measure medication adherence across 11 items covering forgetfulness, intentional skipping, complex regimens, and cost-related non-adherence. Items are rated on a 4-point Likert scale from 0 (Strongly disagree) to 3 (Strongly agree), with total scores 0-33; higher scores indicate better adherence. In addition, pill count (the number of pills not used compared to the number of pills received at the most recent prescription filling) will be used as an objective measurement to confirm medication adherence among participants.	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Self-management behaviours	The Vietnamese version of the Hypertension Self-Care Profile Behaviour Scale (HT-SCPB) will be used to measure self-management behaviour. It includes 20 items that address different aspects of self-management behaviour: checking BP, regular visits to doctors, medication adherence, and lifestyle modifications. Each item will be rated on a 4-point Likert scale from 1 (never/rarely) to 4 (always). The total score 20-80, with a higher score indicating higher hypertension self-management behaviours.	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Self-efficacy	The Vietnamese version of the Self-Efficacy for Managing Chronic Diseases (SEM-CD) scale will assess self-efficacy across six items, including confidence in managing fatigue, pain, emotional distress, other symptoms, health-related tasks, and actions beyond medication. Items are rated on a 10-point Likert scale from 1 (not at all confident) to 10 (totally confident), with the mean score (1-10) representing overall self-efficacy.	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Health literacy	The 12-item Vietnamese Short-Form of Health Literacy Questionnaire (HLS-SF12) will be used to measure HL levels (Duong et al., 2019). It includes twelve items that assess how easy it is for patients to find (4 items), understand (3 items), appraise (3 items) and apply health information (2 items). Each item will be rated on a 4-Likert scale (from 1= "Very difficult" to 4="Very easy"). The total score of the scale will be calculated by the formula HL Index = (Mean-1) x (50/3), where Mean is the average score of the 12 items. The HL Index ranges from 0 to 50; a higher score indicates better HL.	Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Hue University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: self-management; hypertension; health literacy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2025.809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be made available upon reasonable request, subject to ethical approval and data use agreements, to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No