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Not yet recruitingNCT07369479Updated Jan 27, 2026

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

An interventional study of health literacy-tailored self-management intervention in Hypertension (HTN), sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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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Conditions studied

  • Hypertension (HTN)

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Keywords

  • hypertension
  • self-management
  • health literacy
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In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's planned enrollment of 170 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Behavioral: health literacy-tailored self-management intervention

  • No intervention
    Control group

    The participants in the control group will receive care as usual.

Interventions

  • Behavioralhealth 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).

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What researchers measure

Primary outcomes

  1. Blood pressure levels

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

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

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — IPD may be made available upon reasonable request, subject to ethical approval and data use agreements, to protect participant confidentiality.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07369479
Lead sponsor
Chinese University of Hong Kong
Collaborators
Hue University of Medicine and Pharmacy
Responsible party
Vo Thi Nhi (Principal Investigator, Chinese University of Hong Kong) — Principal investigator
First posted
Jan 27, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jan 27, 2026

Study contacts

Nhi Thi Vo, PhD post-candidacy
Contact
vtnhi@link.cuhk.edu.hk
(+852) 56257068

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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