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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07369479
Enrollment
170
Registered
2026-01-27
Start date
2026-02-01
Completion date
2027-07-31
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension (HTN)

Keywords

hypertension, self-management, health literacy

Brief 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.

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).

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER
Hue University of Medicine and Pharmacy
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure levelsBaseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)Participants' blood pressure levels will be measured using a validated digital sphygmomanometer.

Secondary

MeasureTime frameDescription
Proportion of participants achieving optimal blood pressure controlBaseline, 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
Medication adherenceBaseline, 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.
Self-management behavioursBaseline, 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.
Self-efficacyBaseline, 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.
Health literacyBaseline, 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.

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026