Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

University Hospital Heidelberg

Status: Completed

Conditions: Hypertension; Diabetes Mellitus

Treatments: Other: DSD; Other: CDP

Study type: Interventional

Funder types: Other

Identifiers

NCT04183413

WHO-PEN@Scale

Details and patient eligibility

About

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.

Enrollment: 3,500 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,500 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform after the emergency decentralization motivated by the COVID-19 outbreak. Healthcare for diabetes and hypertension for complicated cases is provided through physician-led teams at hospitals and health centers. Healthcare for diabetes and hypertension for uncomplicated cases is provided at primary care clinics through nurses.

DSD

Experimental group

Description:

Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.

Treatment:

Other: DSD

CDP

Experimental group

Description:

Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.

Treatment:

Other: CDP