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Not yet recruiting NCT07369479

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

No phase Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: health literacy-tailored self-management intervention.
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral health 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).

Primary outcome measures

  • Blood pressure levels [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]
Secondary outcome measures (5)
  • Proportion of participants achieving optimal blood pressure control [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]
  • Medication adherence [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]
  • Self-management behaviours [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]
  • Self-efficacy [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]
  • Health literacy [Time frame: Baseline, T1 (immediately post-intervention) and T2 (3 months post-intervention)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07369479 · 2025.809

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗