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NCT Number: NCT04183413

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Noncommunicable Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinton Health Access Initiative

Mbabane, Eswatini

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DSD

Other

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.

CDP

Other

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.

Primary outcomes

  1. Glycemic control (continuous) among adults with diabetes

    Time frame: 12 months

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

  2. Systolic blood pressure among adults with hypertension

    Time frame: 12 months

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

Secondary outcomes

  1. HbA1c among adults with diabetes or prediabetes

    Time frame: 12 months

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

  2. Glycemic control (binary) among adults with diabetes

    Time frame: 12 months

    The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%

  3. Glycemic control (binary) among adults with diabetes or prediabetes

    Time frame: 12 months

    The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%

  4. Awareness of one's diabetes diagnosis

    Time frame: 12 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

  5. Awareness of one's diabetes or prediabetes diagnosis

    Time frame: 12 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

  6. Probability of being treated for diabetes among adults with diabetes

    Time frame: 12 months

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

  7. Probability of having been tested for diabetes among adults with diabetes

    Time frame: 12 months

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

  8. Probability of having been tested for diabetes among adults with diabetes or prediabetes

    Time frame: 12 months

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

  9. Probability of smoking among adults with diabetes, prediabetes, or hypertension

    Time frame: 12 months

    The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker

  10. Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension

    Time frame: 12 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

  11. Systolic blood pressure among adults with diabetes

    Time frame: 12 months

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

  12. Systolic blood pressure among adults with diabetes or prediabetes

    Time frame: 12 months

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

  13. Diastolic blood pressure among adults with diabetes

    Time frame: 12 months

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

  14. Diastolic blood pressure among adults with diabetes or prediabetes

    Time frame: 12 months

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

  15. Hypertension control (binary) among adults with hypertension

    Time frame: 12 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

  16. Diastolic blood pressure among adults with hypertension

    Time frame: 12 months

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

  17. Awareness of one's hypertension diagnosis

    Time frame: 12 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

  18. Probability of being treated for hypertension among adults with hypertension

    Time frame: 12 months

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

  19. Probability of having been tested for hypertension among adults with hypertension

    Time frame: 12 months

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

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

    Time frame: 12 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. 21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension

    Time frame: 12 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.

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Amsterdam Institute for Global Health and Development
  • Clinton Health Access Initiative, Eswatini
  • Diabetes Swaziland
  • SWABCHA, Eswatini
  • Swiss Tropical & Public Health Institute
  • University of Eswatini
  • University of Göttingen

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2019
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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