Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Overview

The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.

Full Title of Study: “Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2021

Interventions

  • Other: PEN
    • This intervention consists of the strengthening of primary healthcare facilities to screen for diabetes and hypertension, and to provide care for uncomplicated cases of these conditions. The intervention will broadly follow the disease screening, management, and referral protocols detailed in the WHO-PEN guidelines and adapted for the Eswatini context during a feasibility pilot.
  • Other: ePEN
    • This arm consists of all activities of arm 2 (the “PEN arm”) plus additional responsibilities for community health workers who are affiliated with the given healthcare facility through the public-sector health system structure. Specifically, community health workers will i) conduct household visits to refer adults aged 40 years and older who have not been screened for diabetes and hypertension in the past 12 months to the primary healthcare facility with which the community health worker is affiliated, ii) provide counseling on reducing one’s risk of cardiovascular disease during these home visits, iii) follow up with individuals whom they referred to a healthcare facility at their home, and iv) provide information on primary and secondary prevention of cardiovascular disease at community meetings.

Arms, Groups and Cohorts

  • No Intervention: Standard of Care
    • Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform. Healthcare for diabetes and hypertension is provided only through physician-led teams at hospitals and health centers.
  • Experimental: PEN
    • Screening for diabetes and hypertension, as well as all care for uncomplicated cases of diabetes and hypertension, will be provided through nurse-lead teams at primary healthcare facilities.
  • Experimental: enhanced PEN (ePEN)
    • This arm consists of all activities of arm 2 (the “PEN arm”) plus additional responsibilities for community health workers.

Clinical Trial Outcome Measures

Primary Measures

  • Glycemic control (continuous) among adults with diabetes
    • Time Frame: 17 months
    • Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes
  • Systolic blood pressure among adults with hypertension
    • Time Frame: 17 months
    • Mean systolic blood pressure among adults aged 40 years and older with hypertension

Secondary Measures

  • HbA1c among adults with diabetes or prediabetes
    • Time Frame: 17 months
    • Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes
  • Glycemic control (binary) among adults with diabetes
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%
  • Glycemic control (binary) among adults with diabetes or prediabetes
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%
  • Awareness of one’s diabetes diagnosis
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey
  • Awareness of one’s diabetes or prediabetes diagnosis
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have been diagnosed with diabetes or prediabetes prior to the household survey
  • Probability of being treated for diabetes among adults with diabetes
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes
  • Probability of having been tested for diabetes among adults with diabetes
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes who report to have been tested for diabetes in the past five years
  • Probability of having been tested for diabetes among adults with diabetes or prediabetes
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have been tested for diabetes in the past five years
  • Probability of smoking among adults with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker
  • Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The mean number of minutes in a typical week spent doing moderate- or vigorous-intensity exercise among adults aged 40 years and older with diabetes
  • Systolic blood pressure among adults with diabetes
    • Time Frame: 17 months
    • Mean systolic blood pressure among adults aged 40 years and older with diabetes
  • Systolic blood pressure among adults with diabetes or prediabetes
    • Time Frame: 17 months
    • Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
  • Diastolic blood pressure among adults with diabetes
    • Time Frame: 17 months
    • Mean diastolic blood pressure among adults aged 40 years and older with diabetes
  • Diastolic blood pressure among adults with diabetes or prediabetes
    • Time Frame: 17 months
    • Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
  • Fruit and vegetable consumption among adults with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The mean number of servings of fruit and vegetables in a typical week among adults aged 40 years and older with diabetes, prediabetes, or hypertension
  • Hypertension control (binary) among adults with hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with hypertension who have a systolic blood pressure <140 mm Hg and a diastolic blood pressure <90 mm Hg
  • Diastolic blood pressure among adults with hypertension
    • Time Frame: 17 months
    • Mean diastolic blood pressure among adults aged 40 years and older with hypertension
  • Awareness of one’s hypertension diagnosis
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey
  • Probability of being treated for hypertension among adults with hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication
  • Probability of having been tested for hypertension among adults with hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with hypertension who report to have had their blood pressure measured in the past five years
  • Cervical cancer screening among women with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of women aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for cervical cancer in the past two years
  • Breast cancer screening among women with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of women aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for breast cancer (by palpation) in the past two years
  • Prostate cancer screening among men with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of men aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for prostate cancer (by digital rectal examination) in the past two years
  • HIV testing among adults with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for HIV in the past two years
  • Tuberculosis testing among adults with diabetes, prediabetes, or hypertension
    • Time Frame: 17 months
    • The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for tuberculosis in the past two years

Participating in This Clinical Trial

Inclusion criteria for the outcome assessment (household survey):

  • Residing in one of the selected households – Age ≥40 years Exclusion criteria for the outcome assessment (household survey): – Pregnant – Inability to provide written informed consent

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital Heidelberg
  • Collaborator
    • Amsterdam Institute for Global Health and Development
  • Provider of Information About this Clinical Study
    • Principal Investigator: Till Bärnighausen, Prof. Dr. Dr. Till Bärnighausen – University Hospital Heidelberg
  • Overall Official(s)
    • Pascal Geldsetzer, MD ScD MPH, Principal Investigator, Heidelberg Institute of Global Health, Heidelberg University
    • Jan-Walter De Neve, MD ScD MPH, Principal Investigator, Heidelberg Institute of Global Health, Heidelberg University
  • Overall Contact(s)
    • Till Bärnighausen, MD ScD, +49 6221 56 5637, till.baernighausen@uni-heidelberg.de

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