Hypertension
Conditions
Keywords
storytelling intervention, home blood pressure monitoring, community health workers, Urban hypertension, Vietnam, HTN-URBAN intervention
Brief summary
The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.
Detailed description
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.
Interventions
BEHAVIORALStorytelling intervention
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.
BEHAVIORALHome BP monitoring
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.
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.
BEHAVIORAL"Learn More" module only
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.
Sponsors
University of Massachusetts, Worcester
National Heart, Lung, and Blood Institute (NHLBI)
Health Strategy and Policy Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Cluster randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years old; * Presence of uncontrolled HTN (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) according to JNC-8; * Willing to provide informed consent.
Exclusion criteria
* Participation in another study on hypertension; * Pregnant; * Advanced cognitive impairment; * Previous exposure to storytelling modules; * Participant family member; * Participant in intervention development.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption | at baseline, 3, 6, and 12 month follow-up visits | 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. |
| Fidelity | at 3, 6, and 12 month follow-up visits | 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. |
| Systolic blood pressure level | From baseline to 3, 6 and 12 month follow up visits | Changes in systolic blood pressure levels |
| Acceptability, Appropriateness, Feasibility | at 3, 6, and 12 month follow-up visits | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of cardiovascular disease (CVD) | From baseline to follow-up at 12 months | Changes in CVD risk factors (tobacco use, alcohol consumption, salt intake and physical activities), which will be measured using WHO STEPs questionnaires |
| Patient quality of life | From baseline to 3, 6 and 12 month follow up visits | Changes in patient's quality of life, which will be measured using the SF-12 survey. |
| Self-efficacy | From baseline to follow-up at 3, 6, and 12 months | Changes in patients medication adherence self-efficacy, which will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument. |
| Cost | at 12 month follow up | 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. |
| Diastolic blood pressure level | From baseline to 3, 6 and 12 months | Changes in diastolic blood pressure levels |
| Hypertension control | From 3 to 6 and12 months follow up visits | Changes in the proportion of patients with hypertension control. |
| Hypertension (HTN) medication adherance | From baseline to 3, 6, and 12 month follow-up visits | Changes in adherence to anti-HTN medications, which will be measured using a standardized data collection form. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORHoa Nguyen, MD, MS, PhD
University of Massachusetts, Worcester
Outcome results
None listed