We are going to employ the innovative intervention called storytelling using interactive literature and culturally sensitive stories from people who successfully controlled their hypertension living in similar communities, having similar access to health services and similar social status as our target participants
This cluster-randomized trial of 16 rural communes (community) health centers is designed to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure among adults residing in the rural Red River Delta region of Vietnam.
Our goal is to continue to improve blood pressure control and associated cardiovascular risk factors in Vietnam, in conjunction with the ongoing work by the Vietnam National Hypertension Program.
- To conduct pre-implementation local needs assessment and formative planning in 16 partnering communities in Hung Yen province, Vietnam leading to a context-specific protocol for implementing the Vietnam National Hypertension Program in both intervention and comparison communities and proposed enhancements (expanded community health worker services, home blood pressure self-monitoring, and storytelling) in the intervention communities only.
- To implement a cluster-randomized trial (Type I Hybrid Implementation Design) of 16 communities and 600 patients randomized to an intervention group (Vietnam National Hypertension Program + enhancements) or comparison group. (Vietnam National Hypertension Program alone.)
- To compare the effectiveness and implementation success of the two approaches using data from multiple sources at multiple points in time, including blood pressure measurements, patient surveys, and interviews with clinic personnel and clinicians.
After approval by the Ministry of Health in Vietnam, the project established a study site of four districts in Hung Yen Province with local focal points selected at all levels (province, district, and commune) and a steering committee at the central level. In May 2018, our US team visited the Vietnam site, to review the results of the needs assessment survey that was conducted at the study site.
During this visit, we also held discussions in preparation for the trial intervention and the development phase. Since June of 2018, the project has been developing intervention tools (Story-telling DVDs) by conducting story development group discussions with patients, to select storytelling “stars”; videotaping the “stars”, and editing and producing the DVDs (on-going).
Additionally, the study team has been working with HTN training experts to develop training programs for community health workers in the next few months of 2019. The team has been preparing for patient screenings for the first round of the intervention in the selected communities.
The project will be conducted in four rural districts of Hung Yen Province located in the Red River Delta in northern Vietnam. The province has a population of approximately 1.5 million (87% in rural areas) and is not currently involved in the Vietnam National HTN Program. In Vietnam, the health care system is organized into three levels, including province, district, and commune (community) level.
The grassroots level, which consists of commune health centers and district health centers, are responsible for delivering primary health care services. Each commune health center has at least one village health worker. They provide health education and support the implementation of national health programs.
Sixteen communities will be randomized to either an intervention or comparison group (8 communities each). Eligible and consenting adult participants with hypertension (n = 600) will be assigned to intervention and comparison status.
The interventions will be implemented over a 1 year follow-up period using data from multiple sources at multiple time points. Following the Vietnam National Hypertension Program, a training program for health care workers including physicians and nurses and a health education program for the general public will be implemented in both intervention and control communities.
In addition to the National Hypertension Program, three proposed enhancements will be implemented in the intervention group only including: (i) expanded community health worker (CHW) services (CHWs will receive extensive training in hypertension management to assist patients better management of their BP at home); (ii) Storytelling intervention (interactive, literacy-appropriate, and culturally sensitive stories of patients speaking in their own voices, delivered by DVD at enrollment and at 3, 6, and 9 months after enrollment to motivate behavior changes) (iii) Home BP self-monitoring (patients will be provided BP monitors and guided to self-measure and record their BP daily at home).
The study outcomes will be measured at 3, 6, and 12 months after trial enrollment. The primary outcome is change in systolic blood pressure; This will be assessed in both study groups. The secondary outcomes include: (i) Change from baseline in diastolic BP assessed in both study groups; (ii) Change in medication adherence self-efficacy score; (iii) Patients medication adherence self-efficacy (the Medication Adherence Self-efficacy Scale); (iv) Change from the baseline in proportions of patients with risk factors for CVD (WHO STEPs questionnaires).
If the intervention is shown to be effective, transforming evidence into a policy-making process will be implemented to scale up the intervention and make it more broadly available.
The process will start with a dissemination workshop with the participation of a Vice-MOH, policymakers, and stakeholders related to the prevention of NCDs in Vietnam.
Following the workshop, an advisory board will be formed to translate the evidence from this trial to the policy arena. It is our hope that the intervention will be utilized and adapted for use, in other provinces throughout Vietnam.
We are pleased to partner with the following organisations: