NCT03590691

Brief Summary

The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design. Sixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
671

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

May 31, 2018

Last Update Submit

May 10, 2023

Conditions

Hypertension

Keywords

storytelling

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in systolic blood pressure at 12 months

    Changes in systolic blood pressure will be assessed in both study groups at several follow-up time points.

    At baseline and at 3, 6, and 12 months after trial enrollment

Secondary Outcomes (3)

  • Change from baseline in diastolic blood pressure at 12 months

    At baseline and at 3, 6, and 12 months after trial enrollment

  • Change from baseline in medication adherence self-efficacy score at 12 months

    At baseline and 12 months after trial enrollment

  • Changes from the baseline in proportions of patients with risk factors for CVD at 12 months

    At baseline and 12 months after trial enrollment

Study Arms (2)

Comparison group

ACTIVE COMPARATOR

Vietnam National Hypertension Program: a training program for health care workers and a health educational program for general public.

Other: Vietnam National Hypertension Program

Intervention group

EXPERIMENTAL

Vietnam National Hypertension Program including training program for health care workers and an health educational program for general public. PLUS Three selected enhancements integrated into routine clinical care: 1. expanded community health worker services; 2. home blood pressure self-monitoring; and 3. a "storytelling intervention".

Other: Vietnam National Hypertension ProgramOther: Expanded community health worker servicesBehavioral: Storytelling interventionBehavioral: Home blood pressure self-monitoring

Interventions

Vietnam National Hypertension ProgramOTHER

A training program for health care workers including physicians and nurses and a health educational program for general public regarding hypertension management at community level will be implemented

Comparison groupIntervention group
Expanded community health worker servicesOTHER

A training program will be implemented for community health workers regarding hypertension management at community level so that they can assist patients better manage their blood pressure at home.

Intervention group
Storytelling interventionBEHAVIORAL

The storytelling intervention consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. Based on preferences that emerged during the researchers' formative work with the partnering rural communities, the storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 12 months after trial enrollment.

Intervention group
Home blood pressure self-monitoringBEHAVIORAL

Patients with hypertension will be provided blood pressure monitors and guided to self-measure their blood pressure and to record their blood pressure daily at home.

Intervention group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residence in a study commune;
  • at least 25 years old;
  • presence of uncontrolled HTN based on the screening process described previously and
  • willingness to provide informed consent.

You may not qualify if:

  • participation in another hypertension research study;
  • pregnant;
  • advanced cognitive impairment; or
  • previous participation in developing or having exposure to the hypertension storytelling modules.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Strategy and Policy Institute

Hanoi, 10000, Vietnam

Location

Related Publications (3)

  • Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.

    PMID: 39045484DERIVED

  • Nguyen HL, Tran OT, Ha DA, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Chiriboga G, Goldberg RJ, Allison JJ. Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam. PLoS One. 2021 Jul 15;16(7):e0253664. doi: 10.1371/journal.pone.0253664. eCollection 2021.

    PMID: 34264973DERIVED

  • Ha DA, Tran OT, Nguyen HL, Chiriboga G, Goldberg RJ, Phan VH, Nguyen CT, Nguyen GH, Pham HV, Nguyen TT, Le TT, Allison JJ. Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial. Trials. 2020 Nov 27;21(1):985. doi: 10.1186/s13063-020-04917-8.

    PMID: 33246495DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tran Thi Mai Oanh, PhD

    Health Strategy and Policy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A cluster-randomized trial design
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Director of Health Strategy and Policy Institute

Study Record Dates

First Submitted

May 31, 2018

First Posted

July 18, 2018

Study Start

November 7, 2019

Primary Completion

January 31, 2023

Study Completion

April 30, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)