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Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

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ClinicalTrials.gov Identifier: NCT01844596
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
Moi University
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hypertension High Blood Pressure Behavioral: behavioral communication strategy Behavioral: Behavioral communication strategy, plus smartphone-based tool Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Linkage and Retention to Hypertension Care in Rural Kenya
Study Start Date : April 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844596


Locations
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Kenya
Moi University School of Medicine
Eldoret, Kenya
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Moi University
Investigators
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Principal Investigator: Valentin Fuster, MD, PhD Icahn School of Medicine at Mount Sinai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01844596     History of Changes
Other Study ID Numbers: GCO 11-1056
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by Icahn School of Medicine at Mount Sinai:
hypertension management
linkage to care
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
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases