Hypertension (HTN)NCT07369479
Effects of a Health Literacy-tailored Self-management Intervention on People With Hypertension
A study testing health literacy-tailored self-management intervention in people with Hypertension (HTN), run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- health literacy-tailored self-management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women
- Patients with secondary hypertension, psychiatric disorders or cognitive impairments.
- Unable to answer telephone calls.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hypertension (HTN)
- Being tested
- health literacy-tailored self-management intervention
- Keywords
- hypertension, self-management, health literacy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health literacy-tailored self-management interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: health literacy-tailored self-management intervention |
| Control group | No intervention | The participants in the control group will receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure levels
Participants' blood pressure levels will be measured using a validated digital sphygmomanometer.
Measured: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hue University of Medicine and Pharmacy
- Responsible party
- Principal investigator, Vo Thi Nhi, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369479
- Sponsor's protocol ID
- 2025.809
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be made available upon reasonable request, subject to ethical approval and data use agreements, to protect participant confidentiality.