Optimizing Linkage and Retention to Hypertension Care in Rural Kenya

This study is not yet open for participant recruitment.
Verified March 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: March 17, 2014
Last verified: March 2014

April 29, 2013
March 17, 2014
April 2014
December 2016   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01844596 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Optimizing Linkage and Retention to Hypertension Care in Rural Kenya
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hypertension
  • High Blood Pressure
  • Behavioral: behavioral communication strategy
    Community Health Workers with an additional tailored behavioral communication strategy.
  • 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).
  • 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.
    Intervention: Behavioral: 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).
    Intervention: Behavioral: Behavioral communication strategy, plus smartphone-based tool
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
5424
March 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rajesh Vedanthan, MD, MPH 212-659-9180 rajesh.vedanthan@mssm.edu
Contact: Claire Hutchinson 212-659-9220 claire.hutchinson@mssm.edu
Kenya
 
NCT01844596
GCO 11-1056
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Moi University
Principal Investigator: Valentin Fuster, MD, PhD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP