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NCT Number: NCT01844596

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases High Blood Pressure Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi University School of Medicine

Eldoret, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral communication strategy

Behavioral

Community Health Workers with an additional tailored behavioral communication strategy.

Behavioral communication strategy, plus smartphone-based tool

Behavioral

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

Primary outcomes

  1. Documented linkage to care following home-based testing

    Time frame: up to 5 years

    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."

  2. One year change in systolic blood pressure among hypertensive individuals

    Time frame: up to one year

    One year change in systolic blood pressure among hypertensive individuals.

Secondary outcomes

  1. Blood Pressure controlled

    Time frame: up to 5 years

    Percentage of hypertensive individuals whose BP is controlled (<140/90) at the final clinic visit

  2. Medication adherence

    Time frame: up to 5 years

    Medication adherence will be defined as number of doses taken divided by number of doses prescribed, for the previous one month.

  3. behavioral changes

    Time frame: up to 5 years

    Behavioral changes include physical activity, diet (salt, fruit/vegetable intake), and tobacco use.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Moi University

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 1, 2013
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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