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NCT Number: NCT07369479

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

health literacy-tailored self-management intervention

Behavioral

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).

Primary outcomes

  1. Blood pressure levels

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    Participants' blood pressure levels will be measured using a validated digital sphygmomanometer.

Secondary outcomes

  1. Proportion of participants achieving optimal blood pressure control

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    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

  2. Medication adherence

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    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.

  3. Self-management behaviours

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    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.

  4. Self-efficacy

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    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.

  5. Health literacy

    Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nhi Thi Vo, PhD post-candidacy

CONTACT

[email protected]

(+852) 56257068

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hue University of Medicine and Pharmacy

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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