Clinical trial NCT04183413: Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini
Official title: Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: Diabetes Mellitus
Diabetes
Hypertension
WHO-PEN
Health service decentralization
Community Health Worker
Eswatini
Swaziland
Scale-up
Implementation research
Cost-effectiveness
Mixed methods
Comorbidity
Non-Communicable Disease
Cardiovascular disease risk factors
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Amsterdam Institute for Global Health and Development
name: Swiss Tropical & Public Health Institute
name: Clinton Health Access Initiative, Eswatini
name: University of Göttingen
name: University of Eswatini
name: SWABCHA, Eswatini
name: Diabetes Swaziland
First posted: 2019-12-03
Enrollment: 3500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel three-arm cluster-randomized trial without a baseline assessment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Glycemic control (continuous) among adults with diabetes
timeFrame: 12 months
measure: Systolic blood pressure among adults with hypertension
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c among adults with diabetes or prediabetes
timeFrame: 12 months
measure: Glycemic control (binary) among adults with diabetes
timeFrame: 12 months
measure: Glycemic control (binary) among adults with diabetes or prediabetes
timeFrame: 12 months
measure: Awareness of one's diabetes diagnosis
timeFrame: 12 months
measure: Awareness of one's diabetes or prediabetes diagnosis
timeFrame: 12 months
measure: Probability of being treated for diabetes among adults with diabetes
timeFrame: 12 months
measure: Probability of having been tested for diabetes among adults with diabetes
timeFrame: 12 months
measure: Probability of having been tested for diabetes among adults with diabetes or prediabetes
timeFrame: 12 months
measure: Probability of smoking among adults with diabetes, prediabetes, or hypertension
timeFrame: 12 months
measure: Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension
timeFrame: 12 months
measure: Systolic blood pressure among adults with diabetes
timeFrame: 12 months
measure: Systolic blood pressure among adults with diabetes or prediabetes
timeFrame: 12 months
measure: Diastolic blood pressure among adults with diabetes
timeFrame: 12 months
measure: Diastolic blood pressure among adults with diabetes or prediabetes
timeFrame: 12 months
measure: Hypertension control (binary) among adults with hypertension
timeFrame: 12 months
measure: Diastolic blood pressure among adults with hypertension
timeFrame: 12 months
measure: Awareness of one's hypertension diagnosis
timeFrame: 12 months
measure: Probability of being treated for hypertension among adults with hypertension
timeFrame: 12 months
measure: Probability of having been tested for hypertension among adults with hypertension
timeFrame: 12 months
measure: Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension
timeFrame: 12 months
measure: 21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension
timeFrame: 12 months
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: Clinton Health Access Initiative
Study officials:
affiliation: Stanford University
name: Pascal Geldsetzer, MD ScD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg Institute of Global Health, Heidelberg University
name: Jan-Walter De Neve, MD ScD MPH
role: PRINCIPAL_INVESTIGATOR
References: