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Study protocol
Hoa Nguyen
Baylor Scott and White Research Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4998-8510
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Vietnam has been experiencing an epidemiologic transition to that of a low-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. 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.
Methods
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. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program.
In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home blood pressure (BP) self-monitoring; and (3) a “storytelling intervention.”. which 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. The storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.
Discussion
Results from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.
Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).
Protocol version: 6. Date: 08/15/2019
Keywords
hypertension, self- monitoring blood pressure, storytelling, trial, Vietnam
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 17 Nov, 2020
Review #4 received
Received 07 Nov, 2020
Reviewer #5 agreed
On 05 Nov, 2020
Review #5 received
Received 05 Nov, 2020
Reviewer #4 agreed
On 04 Nov, 2020
Review #3 received
Received 04 Nov, 2020
Review #1 received
Received 04 Nov, 2020
Review #2 received
Received 04 Nov, 2020
Reviewer #2 agreed
On 03 Nov, 2020
Reviewer #3 agreed
On 03 Nov, 2020
Reviewers invited
Invitations sent on 03 Nov, 2020
Reviewer #1 agreed
On 03 Nov, 2020
Editor assigned
On 31 Oct, 2020
Submission checks complete
On 11 May, 2020
Version 1
Posted 22 Jul, 2020
No comments provided
Review #2 received
Received 01 Oct, 2020
Editorial decision: Major revision
On 01 Oct, 2020
Review #6 received
Received 28 Sep, 2020
Review #5 received
Received 27 Sep, 2020
Review #1 received
Received 22 Sep, 2020
Review #3 received
Received 15 Sep, 2020
Reviewer #6 agreed
On 15 Sep, 2020
Review #4 received
Received 15 Sep, 2020
Reviewer #4 agreed
On 12 Sep, 2020
Reviewer #5 agreed
On 12 Sep, 2020
Reviewer #3 agreed
On 10 Sep, 2020
Reviewers invited
Invitations sent on 09 Sep, 2020
Reviewer #1 agreed
On 09 Sep, 2020
Reviewer #2 agreed
On 09 Sep, 2020
Editor assigned
On 01 Aug, 2020
Submission checks complete
On 20 Jul, 2020
First submitted
On 13 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Hoa Nguyen
Baylor Scott and White Research Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4998-8510
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 17 Nov, 2020
Review #4 received
Received 07 Nov, 2020
Reviewer #5 agreed
On 05 Nov, 2020
Review #5 received
Received 05 Nov, 2020
Reviewer #4 agreed
On 04 Nov, 2020
Review #3 received
Received 04 Nov, 2020
Review #1 received
Received 04 Nov, 2020
Review #2 received
Received 04 Nov, 2020
Reviewer #2 agreed
On 03 Nov, 2020
Reviewer #3 agreed
On 03 Nov, 2020
Reviewers invited
Invitations sent on 03 Nov, 2020
Reviewer #1 agreed
On 03 Nov, 2020
Editor assigned
On 31 Oct, 2020
Submission checks complete
On 11 May, 2020
Version 1
Posted 22 Jul, 2020
No comments provided
Review #2 received
Received 01 Oct, 2020
Editorial decision: Major revision
On 01 Oct, 2020
Review #6 received
Received 28 Sep, 2020
Review #5 received
Received 27 Sep, 2020
Review #1 received
Received 22 Sep, 2020
Review #3 received
Received 15 Sep, 2020
Reviewer #6 agreed
On 15 Sep, 2020
Review #4 received
Received 15 Sep, 2020
Reviewer #4 agreed
On 12 Sep, 2020
Reviewer #5 agreed
On 12 Sep, 2020
Reviewer #3 agreed
On 10 Sep, 2020
Reviewers invited
Invitations sent on 09 Sep, 2020
Reviewer #1 agreed
On 09 Sep, 2020
Reviewer #2 agreed
On 09 Sep, 2020
Editor assigned
On 01 Aug, 2020
Submission checks complete
On 20 Jul, 2020
First submitted
On 13 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background
Vietnam has been experiencing an epidemiologic transition to that of a low-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. 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.
Methods
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. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program.
In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home blood pressure (BP) self-monitoring; and (3) a “storytelling intervention.”. which 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. The storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.
Discussion
Results from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.
Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).
Protocol version: 6. Date: 08/15/2019
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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