We Talk About Our Hypertension

NCT ID: NCT02483780

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Storytelling

Intervention Type BEHAVIORAL

The intervention will center on stories about living with hypertension, with patients speaking in their own words.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Storytelling

The intervention will center on stories about living with hypertension, with patients speaking in their own words.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role collaborator

Institute of Population, Health and Development, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hoa Nguyen, MD, Ph.D

Role: STUDY_DIRECTOR

Institute of Population, Health and Development

Locations

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Institute of Population, Health and Development (PHAD)

Hà Nội, , Vietnam

Site Status

Countries

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Vietnam

References

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Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018.

Reference Type DERIVED
PMID: 30596749 (View on PubMed)

Nguyen HL, Allison JJ, Ha DA, Chiriboga G, Ly HN, Tran HT, Nguyen CK, Dang DM, Phan NT, Vu NC, Nguyen QP, Goldberg RJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 May 1;3:22. doi: 10.1186/s40814-017-0136-9. eCollection 2017.

Reference Type DERIVED
PMID: 28473924 (View on PubMed)

Allison JJ, Nguyen HL, Ha DA, Chiriboga G, Ly HN, Tran HT, Phan NT, Vu NC, Kim M, Goldberg RJ. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial. Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6.

Reference Type DERIVED
PMID: 26762128 (View on PubMed)

Other Identifiers

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2014/PHAD/UMMS 01-01

Identifier Type: -

Identifier Source: org_study_id

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