Clinical trial NCT01844596: Optimizing Linkage and Retention to Hypertension Care in Rural Kenya
Official title: Optimizing Linkage and Retention to Hypertension Care in Rural Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
High Blood Pressure
Keywords: linkage to care
hypertension management
behavioral science
cardiovascular health
global health
multi-disciplinary implementation research approach
linking and retaining
community health workers
CHWs
behavioral communication strategy
smartphone-based tool
electronic health record
retention to care
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Moi University
First posted: 2013-05-01
Enrollment: 1455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Hypertension awareness, treatment, and control rates are low in most regions of the world. 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 Academic Model Providing Access to Healthcare (AMPATH) Partnership 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. To address this challenge, we propose to develop and evaluate innovative community-based strategies and initiatives supported by mobile technology.

The 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. The central hypothesis is: community health workers (CHWs), equipped with a tailored behavioral communication strategy and a smartphone-based tool linked to an electronic health record, can increase linkage and retention of hypertensive individuals to a hypertension care program and thereby significantly reduce blood pressure among these patients. We further hypothesize that these interventions will be cost-effective.

This research will generate innovative and productive solutions to the expanding global problem of hypertension, and will add to existing knowledge on scalable and sustainable strategies for effectively managing hypertension and other chronic diseases in low- and middle-income countries.

Eligibility criteria: 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

Primary outcomes:
measure: Documented linkage to care following home-based testing
timeFrame: up to 5 years
measure: One year change in systolic blood pressure among hypertensive individuals
timeFrame: up to one year
Secondary outcomes:
measure: Blood Pressure controlled
timeFrame: up to 5 years
measure: Medication adherence
timeFrame: up to 5 years
measure: behavioral changes
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Valentin Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vedanthan R, Kamano JH, DeLong AK, Naanyu V, Binanay CA, Bloomfield GS, Chrysanthopoulou SA, Finkelstein EA, Hogan JW, Horowitz CR, Inui TS, Menya D, Orango V, Velazquez EJ, Were MC, Kimaiyo S, Fuster V. Community Health Workers Improve Linkage to Hypertension Care in Western Kenya. J Am Coll Cardiol. 2019 Oct 15;74(15):1897-1906. doi: 10.1016/j.jacc.2019.08.003. Epub 2019 Sep 2.
citation: Vedanthan R, Kamano JH, Naanyu V, Delong AK, Were MC, Finkelstein EA, Menya D, Akwanalo CO, Bloomfield GS, Binanay CA, Velazquez EJ, Hogan JW, Horowitz CR, Inui TS, Kimaiyo S, Fuster V. Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:143. doi: 10.1186/1745-6215-15-143.