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Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Not Applicable
Completed
Conditions
Diabetes Mellitus
Hypertension
Interventions
Other: CDP
Other: DSD
Registration Number
NCT04183413
Lead Sponsor
University Hospital Heidelberg
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3500
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CDPCDPHealth services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.
DSDDSDClients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.
Primary Outcome Measures
NameTimeMethod
Glycemic control (continuous) among adults with diabetes12 months

Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes

Systolic blood pressure among adults with hypertension12 months

Mean systolic blood pressure among adults aged 40 years and older with hypertension

Secondary Outcome Measures
NameTimeMethod
Systolic blood pressure among adults with diabetes or prediabetes12 months

Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes

Diastolic blood pressure among adults with diabetes12 months

Mean diastolic blood pressure among adults aged 40 years and older with diabetes

Diastolic blood pressure among adults with diabetes or prediabetes12 months

Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes

Diastolic blood pressure among adults with hypertension12 months

Mean diastolic blood pressure among adults aged 40 years and older with hypertension

HbA1c among adults with diabetes or prediabetes12 months

Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes

Glycemic control (binary) among adults with diabetes12 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 prediabetes12 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 diagnosis12 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 diagnosis12 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 having been tested for diabetes among adults with diabetes or prediabetes12 months

The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have ever been tested for diabetes

Probability of smoking among adults with diabetes, prediabetes, or hypertension12 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 hypertension12 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

Awareness of one's hypertension diagnosis12 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 hypertension12 months

The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication

Probability of being treated for diabetes among adults with diabetes12 months

The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes

Systolic blood pressure among adults with diabetes12 months

Mean systolic blood pressure among adults aged 40 years and older with diabetes

Probability of having been tested for diabetes among adults with diabetes12 months

The proportion of adults aged 40 years and older with diabetes who report to have ever been tested for diabetes

Probability of having been tested for hypertension among adults with hypertension12 months

The proportion of adults aged 40 years and older with hypertension who report to have ever had their blood pressure measured

Hypertension control (binary) among adults with hypertension12 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

Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension12 months

The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to having drunk daily, 5-6 days per week, 3-4 days per week, 1-2 days per week, 1-3 days per month, less than once a month, or never over the past 12 months.

21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension12 months

The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who correctly responded to each individual question on diabetes and hypertension related knowledge.

Trial Locations

Locations (1)

Clinton Health Access Initiative

🇸🇿

Mbabane, Swaziland

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