Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Moi University
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01844596
First received: April 29, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hypertension
High Blood Pressure
Behavioral: behavioral communication strategy
Behavioral: Behavioral communication strategy, plus smartphone-based tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Documented linkage to care following home-based testing [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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."

  • One year change in systolic blood pressure among hypertensive individuals [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    One year change in systolic blood pressure among hypertensive individuals.


Secondary Outcome Measures:
  • Blood Pressure controlled [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Percentage of hypertensive individuals whose BP is controlled (<140/90) at the final clinic visit

  • Medication adherence [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Medication adherence will be defined as number of doses taken divided by number of doses prescribed, for the previous one month.

  • behavioral changes [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Behavioral changes include physical activity, diet (salt, fruit/vegetable intake), and tobacco use.


Estimated Enrollment: 5424
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844596

Contacts
Contact: Rajesh Vedanthan, MD, MPH 212-659-9180 rajesh.vedanthan@mssm.edu
Contact: Claire Hutchinson 212-659-9220 claire.hutchinson@mssm.edu

Locations
Kenya
Moi University School of Medicine Recruiting
Eldoret, Kenya
Contact: Jackson Rotich    254-721-477-364    rojacks83@yahoo.com   
Principal Investigator: Jemima Kamano, MBChB, MMed         
Sponsors and Collaborators
Mount Sinai School of Medicine
Moi University
Investigators
Principal Investigator: Valentin Fuster, MD, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01844596     History of Changes
Other Study ID Numbers: GCO 11-1056
Study First Received: April 29, 2013
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board
Kenya: Moi University Institutional Research Ethics Committee

Keywords provided by Mount Sinai School of Medicine:
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014