We Talk About Our Hypertension

April 4, 2017 updated by: Institute of Population, Health and Development, Vietnam

Culturally Adaptive Storytelling Method to Improve Hypertension Control in Vietnam -"We Talk About Our Hypertension": a Pilot Cluster Randomized Controlled Trial

The proposed pilot community-based research project will examine the feasibility, acceptability, and potential efficacy of the Storytelling intervention compared with usual care in hypertension control among rural residents in 4 communities in Vietnam. This is a major clinical and public health problem in this developing country.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ha Noi, Vietnam
        • Institute of Population, Health and Development (PHAD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Consenting adult men and women must fulfill each of the following criteria:

  1. be a resident of the selected commune;
  2. be aged 50 years or older;
  3. have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7)
  4. not be cognitively impaired (as assessed by study physicians)
  5. not be a "story teller" used to develop the intervention;
  6. not be a family member of another participant in the study

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Storytelling intervention

Two communes will be assigned to intervention group. Within each commune, 25 adults with HTN will be enrolled.

Patients will receive 2 DVDs with stories of patients who have successfully controlled their hypertension and "Learn More" section, which will be coordinated with specific patient stories and will fill in gaps not covered by the storytellers.
Behavioral: Storytelling
The intervention will center on stories about living with hypertension, with patients speaking in their own words.
NO_INTERVENTION: Usual care

Two communes will be assigned to usual care group. Within each commune, 25 adults with HTN will be enrolled.

Patients will receive 2 DVDs with only didactic material about common non-communicable diseases but without hypertension related stories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recruitment rate
Time Frame: 3 months
3 months
retention rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 3 months after randomization
systolic and diastolic BP and the proportion of participants with controlled BP defined as in JNC-8
3 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Population, Health and Development, Vietnam

Collaborators

University of Massachusetts, Worcester

Investigators

  • Study Director: Hoa Nguyen, MD, Ph.D, Institute of Population, Health and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (ESTIMATE)

June 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/PHAD/UMMS 01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Storytelling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe