HypertensionNCT02483780
We Talk About Our Hypertension
A study testing Storytelling in people with Hypertension, run by Institute of Population, Health and Development, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Storytelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adult men and women must fulfill each of the following criteria:
- be a resident of the selected commune;
- be aged 50 years or older;
- have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7)
- not be cognitively impaired (as assessed by study physicians)
- not be a "story teller" used to develop the intervention;
- not be a family member of another participant in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Storytelling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StorytellingBehavioural
The intervention will center on stories about living with hypertension, with patients speaking in their own words.
| Study group | Role | What they receive |
|---|---|---|
| Storytelling intervention | 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. Receives: Behavioral: Storytelling |
| Usual care | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rate
Measured: 3 months
retention rate
Measured: 1 year
Secondary outcomes (1)
Blood pressure
systolic and diastolic BP and the proportion of participants with controlled BP defined as in JNC-8
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Population, Health and Development, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Hoa Nguyen, MD, Ph.D, Study director, Institute of Population, Health and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483780
- Sponsor's protocol ID
- 2014/PHAD/UMMS 01-01
- Status last verified
- Apr 2017
- First submitted
- 22 Jun 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30596749Nguyen 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.
PubMed 28473924Allison 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.
PubMed 26762128
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adaptive Storytelling Method to Improve Hypertension Control in Vietnam -"We Talk About Our Hypertension": a Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02483780
- Acronym / sponsor ID
- 2014/PHAD/UMMS 01-01
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Institute of Population, Health and Development, VietnamUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storytelling intervention | Experimental | Behavioral: StorytellingTwo 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. |
| Usual care | 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be a resident of the selected commune;
- be aged 50 years or older;
- have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7)
- not be cognitively impaired (as assessed by study physicians)
- not be a "story teller" used to develop the intervention;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StorytellingThe intervention will center on stories about living with hypertension, with patients speaking in their own words. | Behavioural | Storytelling intervention |
Primary outcome
recruitment rate
Time frame: 3 months
retention rate
Time frame: 1 year
1 secondary outcome
Blood pressure
Time frame: 3 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 30596749Nguyen 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.
- Derived from this study: PubMed 28473924Nguyen 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.
- Derived from this study: PubMed 26762128Allison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoa Nguyen, MD, Ph.D study director
Institute of Population, Health and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling in people with Hypertension, run by Institute of Population, Health and Development, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.