Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Study Overview
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Brief Summary
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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.

Official Title
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Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial

Conditions
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Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Other: DSD
* Other: CDP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel three-arm cluster-randomized trial without a baseline assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Experimental: DSD<br>Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs. | Other: DSD<br>* This intervention consist of three Differentiated Service Delivery Models in which stable clients can be enrolled. The fast-track model gives preferential treatment to enrolled clients. Clients arrive at clinics, usually early in the morning, and can see the nurse as well as collect their medication without queuing. This model mainly targets the working population. The facility-based treatment clubs consist of bimonthly meetings where clients meet in groups of approximately 20 members. They receive health counselling, risk factor screening and medication prescription. This model mainly targets clients living close to the facility. The community advisory groups consist of groups of up to six clients. Groups are equipped with a point of care blood pressure and blood glucose measurement devices. They take turns in collecting the medication for the entire group and meet on a monthly basis. This model targets clients in hard-to-reach areas.<br>|
| Experimental: CDP<br>Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities. | Other: CDP<br>* Community Distribution Points are set up on a monthly basis in communities linked to the clinic. Healthcare staff sets up a temporary point of contact where clients can obtain screening for diabetes and hypertension, health counselling, referral to primary or tertiary facilities, and medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control (continuous) among adults with diabetes | Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes | 12 months | 
| Systolic blood pressure among adults with hypertension | Mean systolic blood pressure among adults aged 40 years and older with hypertension | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c among adults with diabetes or prediabetes | Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes | 12 months | 
| Glycemic control (binary) among adults with diabetes | The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0% | 12 months | 
| Glycemic control (binary) among adults with diabetes or prediabetes | The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0% | 12 months | 
| Awareness of one's diabetes diagnosis | The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey | 12 months | 
| Awareness of one's diabetes or prediabetes diagnosis | 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 | 12 months | 
| Probability of being treated for diabetes among adults with diabetes | The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes | 12 months | 
| Probability of having been tested for diabetes among adults with diabetes | The proportion of adults aged 40 years and older with diabetes who report to have ever been tested for diabetes | 12 months | 
| Probability of having been tested for diabetes among adults with diabetes or prediabetes | The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have ever been tested for diabetes | 12 months | 
| Probability of smoking among adults with diabetes, prediabetes, or hypertension | The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker | 12 months | 
| Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension | 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 | 12 months | 
| Systolic blood pressure among adults with diabetes | Mean systolic blood pressure among adults aged 40 years and older with diabetes | 12 months | 
| Systolic blood pressure among adults with diabetes or prediabetes | Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes | 12 months | 
| Diastolic blood pressure among adults with diabetes | Mean diastolic blood pressure among adults aged 40 years and older with diabetes | 12 months | 
| Diastolic blood pressure among adults with diabetes or prediabetes | Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes | 12 months | 
| Hypertension control (binary) among adults with hypertension | 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 | 12 months | 
| Diastolic blood pressure among adults with hypertension | Mean diastolic blood pressure among adults aged 40 years and older with hypertension | 12 months | 
| Awareness of one's hypertension diagnosis | The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey | 12 months | 
| Probability of being treated for hypertension among adults with hypertension | The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication | 12 months | 
| Probability of having been tested for hypertension among adults with hypertension | The proportion of adults aged 40 years and older with hypertension who report to have ever had their blood pressure measured | 12 months | 
| Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension | 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. | 12 months | 
| 21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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