Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183413
• Other study ID #: WHO-PEN@Scale
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Heidelberg
• Contact: Till Bärnighausen, MD ScD
• Phone: +49 6221 56 5637
• Email: till.baernighausen[@]uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Other:
• DSD
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
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.

Locations

Country	Name	City	State
Swaziland	Clinton Health Access Initiative	Mbabane

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital Heidelberg	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

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control (continuous) among adults with diabetes	Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes	12 months
Primary	Systolic blood pressure among adults with hypertension	Mean systolic blood pressure among adults aged 40 years and older with hypertension	12 months
Secondary	HbA1c among adults with diabetes or prediabetes	Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Systolic blood pressure among adults with diabetes	Mean systolic blood pressure among adults aged 40 years and older with diabetes	12 months
Secondary	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
Secondary	Diastolic blood pressure among adults with diabetes	Mean diastolic blood pressure among adults aged 40 years and older with diabetes	12 months
Secondary	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
Secondary	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
Secondary	Diastolic blood pressure among adults with hypertension	Mean diastolic blood pressure among adults aged 40 years and older with hypertension	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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