Hypertension Clinical Trial
Official title:
Optimizing Linkage and Retention to Hypertension Care in Rural Kenya
Verified date | October 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease (CVD) is the leading cause of death in sub-Saharan Africa among adults
above age 30. The prevalence of hypertension, a major risk factor for CVD, is increasing over
time in sub-Saharan Africa, exerting a significant epidemiologic and economic burden on the
region. Without adequate control of hypertension, its health and economic burden will
increase drastically in the decades ahead. Well established and evidence-based interventions
to manage hypertension exist; however, treatment and control rates are low.
A critical component of hypertension management is to facilitate sustained access of affected
individuals to effective clinical services. In partnership with the Government of Kenya, the
United States Agency for International Development-Academic Model Providing Access to
Healthcare Partnership (AMPATH) is expanding its clinical scope of work in rural western
Kenya to include hypertension and other chronic diseases.
However, linking and retaining individuals with elevated blood pressure to the clinical care
program has been difficult. Thus, the overall objective of this application is to utilize a
multi-disciplinary implementation research approach to address the challenge of linking and
retaining hypertensive individuals to a hypertension management program. We aim to add to
existing knowledge on scalable and sustainable strategies for optimizing control of
hypertension and other chronic diseases in low- and middle-income countries.
Status | Completed |
Enrollment | 1455 |
Est. completion date | August 31, 2017 |
Est. primary completion date | August 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years old and older - elevated BP (SBP > 140 or DBP >90) Exclusion Criteria: - acutely ill and require immediate medical attention at the time of home-based testing - individuals who do not provide informed consent during home-based testing |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University School of Medicine | Eldoret |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Moi University |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Documented linkage to care following home-based testing | An individual who links to care on his/her own within one month of home-based blood pressure testing will be characterized as "self-linked" or after a community health worker (CHW) visit, sh/he will be characterized as "CHW-mediated linked." | up to 5 years | |
Primary | One year change in systolic blood pressure among hypertensive individuals | One year change in systolic blood pressure among hypertensive individuals. | up to one year | |
Secondary | Blood Pressure controlled | Percentage of hypertensive individuals whose BP is controlled (<140/90) at the final clinic visit | up to 5 years | |
Secondary | Medication adherence | Medication adherence will be defined as number of doses taken divided by number of doses prescribed, for the previous one month. | up to 5 years | |
Secondary | behavioral changes | Behavioral changes include physical activity, diet (salt, fruit/vegetable intake), and tobacco use. | up to 5 years |
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