NCT01844596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,455

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

April 29, 2013

Last Update Submit

October 18, 2017

Conditions

Keywords

linkage to carehypertension managementbehavioral sciencecardiovascular healthglobal healthmulti-disciplinary implementation research approachlinking and retainingcommunity health workersCHWsbehavioral communication strategysmartphone-based toolelectronic health recordretention to care

Outcome Measures

Primary Outcomes (2)

  • Documented linkage to care following home-based testing

    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."

    up to 5 years

  • One year change in systolic blood pressure among hypertensive individuals

    One year change in systolic blood pressure among hypertensive individuals.

    up to one year

Secondary Outcomes (3)

  • Blood Pressure controlled

    up to 5 years

  • Medication adherence

    up to 5 years

  • behavioral changes

    up to 5 years

Study Arms (3)

Usual Care

NO INTERVENTION

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

behavioral communication strategy

EXPERIMENTAL

Community Health Workers with an additional tailored behavioral communication strategy.

Behavioral: behavioral communication strategy

Behavioral communication strategy, plus smartphone-based tool

EXPERIMENTAL

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

Interventions

Community Health Workers with an additional tailored behavioral communication strategy.

behavioral communication strategy

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

Behavioral communication strategy, plus smartphone-based tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and older
  • elevated BP (SBP \> 140 or DBP \>90)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi University School of Medicine

Eldoret, Kenya

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Valentin Fuster, MD, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

April 1, 2014

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations