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Trial record 1 of 1 for:    NCT03543787
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Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) (STRENGTHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03543787
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : June 29, 2018
Indiana University
Duke University
Icahn School of Medicine at Mount Sinai
Purdue University
University of Texas at Austin
Information provided by (Responsible Party):
Moi University

Brief Summary:
"STRENGTHS" is a transdisciplinary implementation research study, guided by the PRECEDE-PROCEED framework, to address the challenge of improving hypertension control in low-resource settings. The investigators propose to test the hypothesis that referral networks strengthened by an integrated health information technology and peer support intervention will be effective and cost-effective in improving hypertension control among patients in western Kenya. The investigators hypothesise that the integrated Health information Technology and Peer Support intervention will facilitate seamless referral of hypertensive patients across the different levels of the health system compared to usual care, leading to improvement in blood pressure. If proven to be successful, STRENGTHS can serve as a model for improving referral of patients upstream and downstream in health systems worldwide.

Condition or disease Intervention/treatment Phase
Hypertension Combination Product: Health IT and Peer Support Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PRECEDE-PROCEED implementation research framework; 2-arm cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 28, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Health IT and Peer Support Intervention
Utilise electronic decision support, tracking of referral list and Peer facilitation for referral completion
Combination Product: Health IT and Peer Support Intervention

Health IT will support referral system by establishing 1) communication between healthcare providers and peer navigators 2) decision support for clinician to facilitate appropriate referrals 3) tracking of referred patients real-time 4) dashboards to monitor key evaluation metrics.

Peer Support intervention: peer navigators at each level of the referral network will ensure 1) referral adherence by link clinicians and patients 2) health system navigation 3) psychosocial support: leverage their shared disease experience to help patients overcome barriers to health seeking behaviour.

No Intervention: Non intervention group
2014 - 2018 MoH referral protocol

Primary Outcome Measures :
  1. Change in one year systolic blood pressure as measured in clinic [ Time Frame: 1 year ]
    The systolic blood pressure at baseline will be compared to systolic blood after 1 year of follow up. Blood pressure measurements will be averaged from three successive readings taken every 5 minutes in clinic

Secondary Outcome Measures :
  1. Change in one year overall Cardiovascular disease (CVD) QRISK2 score [ Time Frame: 1 year ]
    QRISK2 score is a computerised algorithm for predicting the ten-year risk of developing CVD events. The factors that enter into the calculation of the QRISK2 score include: Age 25-84 years, sex, ethnicity, smoking status, diabetes status, family history of coronary artery disease in first degree relatives below the age of 65 years, chronic kidney disease stages 4 and 5, atrial fibrillation, rheumatoid arthritis, cholesterol / high density lipoprotein ratio, systolic blood pressure, body mass index. A score of 10% or more suggest a 10% risk of primary CVD events in ten years and warrants intervention to reduce the risk. It's not used among patients who already have a heart attack or a stroke.

  2. Mortality [ Time Frame: 1 year follow up ]
    Death at the end of the study

  3. Hospitalisation [ Time Frame: 1 year of follow up ]
    Number of self-reported hospital admissions for hypertensive crises or heart failure among participants over one year follow up.

  4. Cardiovascular disease complications [ Time Frame: 1 year follow up ]
    Any cardiovascular complications including Heart failure, Stroke and Acute myocardial infarction

  5. Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire [ Time Frame: 1 year ]
    Baseline risk factor profile compared to profile at 1 year of the various CVD risk factors as assessed using a standardised CVD risk factors and behaviours screening questionnaire

  6. Self reported adherence to hypertension medication as assessed using the Morisky Medication adherence questionnaire [ Time Frame: 1 year ]
    To assess changes in adherence to hypertension medications at one year from baseline as determined using the Morisky medication adherence questionnaire

Other Outcome Measures:
  1. Referral network characteristics [ Time Frame: 1 year ]
    To assess the referral densities within the healthcare system.

  2. Referral proces characteristics [ Time Frame: 1 year ]
    To assess referral completion rates within the healthcare system

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >= 18 yrs
  • Enrolled in AMPATH CDM Program
  • meet criteria for referral up or down the network

    • Patients with complicated hypertension meet criteria for referral up the network, defined as patients with hypertension who remain uncontrolled (SBP >= 140 or DBP >= 90) on 3 or more anti-hypertensive medications, who have signs or symptoms of end-organ damage, or who have suspected secondary causes of hypertension (age <35 years, HIV, or pregnancy)
    • Patients with stable, uncomplicated hypertension meet criteria for referral down the network, defined as controlled BP (SBP < 140 and DBP < 90) for 3 or more consecutive visits and no evidence of new end-organ damage

Exclusion Criteria:

  • acute illness requiring immediate medical attention
  • terminal illness
  • inability to provide informed consent

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 identifier (NCT number): NCT03543787

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Constantine Akwanalo
Eldoret, Kenya
Sponsors and Collaborators
Moi University
Indiana University
Duke University
Icahn School of Medicine at Mount Sinai
Purdue University
University of Texas at Austin
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Principal Investigator: Constantine O Akwanalo Moi Teaching and Referral Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Moi University Identifier: NCT03543787    
Other Study ID Numbers: 1U01HL138636-01 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After data cleaning and primary analyses, the de-identified data will be available to the scientific community upon formal request made to the AMPATH Research Manager. The data collection instruments will also be available upon request to the AMPATH Research Manager.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moi University:
Referral networks
low and middle income countries
implementation research
cardiovascular disease
process evaluation
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases