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

NCT07369479 | Not Yet Recruiting DMC

• 1 other identifier: 2025.809
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension (HTN)

Keywords

hypertension; self-management; health literacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of participants achieving optimal blood pressure control

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

• Medication adherence

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

• Self-management behaviours

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

• Self-efficacy

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

• Health literacy

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: health literacy-tailored self-management intervention

Control group

NO INTERVENTION

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

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: collaborator
• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Nhi Thi Vo, PhD post-candidacy

CONTACT

(+852) 56257068; vtnhi@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01