Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)

NCT03543787 | Unknown Phase 3 DMC

• 1 other identifier: 1U01HL138636-01
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Referral networks; low and middle income countries; PRECEDE-PROCEED; implementation research; hypertension; cardiovascular disease; process evaluation

Outcome Measures

Primary Outcomes (1)

• Change in one year systolic blood pressure as measured in clinic

  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

  1 year

Secondary Outcomes (6)

• Change in one year overall Cardiovascular disease (CVD) QRISK2 score

  1 year

• Mortality

  1 year follow up

• Hospitalisation

  1 year of follow up

• Cardiovascular disease complications

  1 year follow up

• Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire

  1 year

Other Outcomes (2)

• Referral network characteristics

  1 year

• Referral proces characteristics

  1 year

Study Arms (2)

Health IT and Peer Support Intervention

ACTIVE COMPARATOR

Utilise electronic decision support, tracking of referral list and Peer facilitation for referral completion

Combination Product: Health IT and Peer Support Intervention

Non intervention group

NO INTERVENTION

2014 - 2018 MoH referral protocol

Interventions

Health IT and Peer Support Intervention COMBINATION_PRODUCT

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.

Health IT and Peer Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

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

Sponsors & Collaborators

• Moi University: lead
• Indiana University: collaborator
• Duke University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Purdue University: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

Constantine Akwanalo

Eldoret, Kenya

Location

Related Publications (3)

• Naanyu V, Njuguna B, Koros H, Andesia J, Kamano J, Mercer T, Bloomfield G, Pastakia S, Vedanthan R, Akwanalo C. Community engagement to inform development of strategies to improve referral for hypertension: perspectives of patients, providers and local community members in western Kenya. BMC Health Serv Res. 2023 Aug 11;23(1):854. doi: 10.1186/s12913-023-09847-0.

  PMID: 37568172 DERIVED

• Thakkar A, Valente T, Andesia J, Njuguna B, Miheso J, Mercer T, Mugo R, Mwangi A, Mwangi E, Pastakia SD, Pathak S, Pillsbury MKM, Kamano J, Naanyu V, Williams M, Vedanthan R, Akwanalo C, Bloomfield GS. Network characteristics of a referral system for patients with hypertension in Western Kenya: results from the Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) study. BMC Health Serv Res. 2022 Mar 7;22(1):315. doi: 10.1186/s12913-022-07699-8.

  PMID: 35255913 DERIVED

• Mercer T, Njuguna B, Bloomfield GS, Dick J, Finkelstein E, Kamano J, Mwangi A, Naanyu V, Pastakia SD, Valente TW, Vedanthan R, Akwanalo C. Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial. Trials. 2019 Sep 9;20(1):554. doi: 10.1186/s13063-019-3661-4.

  PMID: 31500661 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Constantine O Akwanalo

  Moi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRECEDE-PROCEED implementation research framework; 2-arm cluster randomized controlled trial

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: June 1, 2018
• Study Start: January 17, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

KE (1)