The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.
A Cluster-randomized, Type II Hybrid effectiveness implementation Trial will take place in 14 urban communities in 7 urban districts in Hai Phong city in northern Vietnam. Community Eligibility Criteria: (1) located in urban Hai Phong city; (2) distance between 2 communities will be at least 10 Km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study. Recruitment Residents from participating sites will be invited to attend the community screening events run by local community health center (CHC) staff and Community Health Workers (CHWs). Those meeting our pre-defined eligibility criteria will be invited to their CHCs to learn more about the study. Patients with elevated blood pressure (BP) will be invited for re-measurement over the next two weeks (at least 1 week apart). After the second BP measurement, patients with elevated BP will be invited to participate in the study. Randomization Fourteen communities in urban Hai Phong (700 patients with uncontrolled hypertension - HTN) will be randomly assigned either to an intervention (7 communities- 50 patients per community) or comparison group (7 communities- 50 patients per community) by a computer procedure. Patients with uncontrolled HTN will be assigned to intervention versus comparison status based on the communities in which they reside. Intervention group: The intervention group will receive 3 components including digital Storytelling delivered via Computerized Intervention Authoring System (CIAS), home blood pressure self-monitoring and expanded CHW services (frequent contacts, visits and consultations). Comparison group: Patients in the comparison group will receive only "Learn More" module - didactic material without HTN related stories via CIAS. Patients in both groups will be followed up at 3, 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
700
The storytelling intervention 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. Based on preferences that emerged during the researchers' formative work with the partnering rural communities, the storytelling intervention will be delivered via Computerized Intervention Authoring System (CIAS) on a biweekly basis. A supplementary "Learn More" module of didactic material (3 minutes) provides strategies for better patient-physician communication and is coordinated with the specific patient stories will be provided via CIAS as well.
Patients with hypertension will be provided blood pressure monitors and guided to self-measure their blood pressure and to record their blood pressure daily at home.
Health Strategy and Policy Institute
Hanoi, Vietnam, Vietnam
Systolic blood pressure level
Changes in systolic blood pressure levels
Time frame: From baseline to 3, 6 and 12 month follow up visits
Acceptability, Appropriateness, Feasibility
Information will be collected via semi-structured interviews among patients, Community health workers, community leaders, and local clinicians and nurses mentioned previously and patient interviews and post-story viewing surveys.
Time frame: at 3, 6, and 12 month follow-up visits
Adoption
Data for participant recruitment and retention will include the number of patients approached for recruitment, reasons for ineligibility of patients not enrolled or refusing to participate, and completion rates for follow-up visits.
Time frame: at baseline, 3, 6, and 12 month follow-up visits
Fidelity
Information will be collected via periodic random observations of blood pressure measurement and patient interviews by study investigators and the project manager who will document and check intervention deliverables using a standardized checklist.
Time frame: at 3, 6, and 12 month follow-up visits
Diastolic blood pressure level
Changes in diastolic blood pressure levels
Time frame: From baseline to 3, 6 and 12 months
Hypertension control
Changes in the proportion of patients with hypertension control.
Time frame: From 3 to 6 and12 months follow up visits
Self-efficacy
Changes in patients medication adherence self-efficacy, which will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.
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A training program will be implemented for community health workers for the intervention arm regarding hypertension management at the community level so that they can assist patients better managing their blood pressure at home.
A supplementary "Learn More" module of didactic material (3 minutes) provides strategies for better patient-physician communication, which will be delivered via Computerized Intervention Authoring System (CIAS) at baseline and at 3, 6, and 9 months after enrollment.
Time frame: From baseline to follow-up at 3, 6, and 12 months
Hypertension (HTN) medication adherance
Changes in adherence to anti-HTN medications, which will be measured using a standardized data collection form.
Time frame: From baseline to 3, 6, and 12 month follow-up visits
Risk of cardiovascular disease (CVD)
Changes in CVD risk factors (tobacco use, alcohol consumption, salt intake and physical activities), which will be measured using WHO STEPs questionnaires
Time frame: From baseline to follow-up at 12 months
Patient quality of life
Changes in patient's quality of life, which will be measured using the SF-12 survey.
Time frame: From baseline to 3, 6 and 12 month follow up visits
Cost
Program costs and patient-related costs will be collected. Program costs include intervention development and its implementation at the district and community levels: personnel, equipment, medical devices, training materials and supplies, transportation, administration, and other operational expenses. Patient-related costs include medications, time lost from work, Community Health Center visits, and consultation fees and patient utilities will be collected using a survey administered at the final visit.
Time frame: at 12 month follow up