Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; High Blood Pressure
• Intervention / Treatment: Behavioral: behavioral communication strategy; Behavioral: Behavioral communication strategy, plus smartphone-based tool

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.

• Study Type: Interventional
• Enrollment (Actual): 1455
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Moi University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care; Usual Care: Community Health Workers (CHW) with standard training on recruitment of individuals.
EXPERIMENTAL: behavioral communication strategy; Community Health Workers with an additional tailored behavioral communication strategy.	Behavioral: behavioral communication strategy; Community Health Workers with an additional tailored behavioral communication strategy.
EXPERIMENTAL: Behavioral communication strategy, plus smartphone-based tool; Community Health Workers with a tailored behavioral communication strategy, also equipped with smartphone-based tool linked to the AMPATH Medical Record System (AMRS).	Behavioral: Behavioral communication strategy, plus smartphone-based tool; Community Health Workers with a tailored behavioral communication strategy, also equipped with smartphone-based tool linked to the AMPATH Medical Record System (AMRS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure controlled	Percentage of hypertensive individuals whose BP is controlled (<140/90) at the final clinic visit	up to 5 years
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
behavioral changes	Behavioral changes include physical activity, diet (salt, fruit/vegetable intake), and tobacco use.	up to 5 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Moi University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (ESTIMATE): May 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: community health workers; cardiovascular health; linkage to care; hypertension management; electronic health record; global health; behavioral science; multi-disciplinary implementation research approach; linking and retaining; CHWs; behavioral communication strategy; smartphone-based tool; retention to care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GCO 11-1056