Overview

This trial is active, not recruiting.

Condition hypertension
Treatment storytelling
Sponsor Institute of Population, Health and Development, Vietnam
Collaborator University of Massachusetts, Worcester
Start date July 2015
End date September 2016
Trial size 100 participants
Trial identifier NCT02483780, 2014/PHAD/UMMS 01-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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.
storytelling
The intervention will center on stories about living with hypertension, with patients speaking in their own words.
(No Intervention)
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.

Primary Outcomes

Measure
recruitment rate
time frame: 3 months
retention rate
time frame: 1 year

Secondary Outcomes

Measure
Blood pressure
time frame: 3 months after randomization

Eligibility Criteria

Male or female participants at least 50 years old.

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:

Additional Information

Official title Culturally Adaptive Storytelling Method to Improve Hypertension Control in Vietnam -"We Talk About Our Hypertension": a Pilot Cluster Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Institute of Population, Health and Development, Vietnam.