Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

NCT ID: NCT01844596

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual Care: Community Health Workers (CHW) with standard training on recruitment of individuals.

Group Type: NO_INTERVENTION

No interventions assigned to this group

behavioral communication strategy

Community Health Workers with an additional tailored behavioral communication strategy.

Group Type: EXPERIMENTAL

behavioral communication strategy

Intervention Type: BEHAVIORAL

Community Health Workers with an additional tailored behavioral communication strategy.

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).

Group Type: EXPERIMENTAL

Behavioral communication strategy, plus smartphone-based tool

Intervention Type: BEHAVIORAL

Community Health Workers with a tailored behavioral communication strategy, also equipped with smartphone-based tool linked to the AMPATH Medical Record System (AMRS).

Interventions

behavioral communication strategy

Community Health Workers with an additional tailored behavioral communication strategy.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moi University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentin Fuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Moi University School of Medicine

Eldoret, , Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 31487546 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24767476 (View on PubMed)

Other Identifiers

GCO 11-1056

Identifier Type: -

Identifier Source: org_study_id