Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

October 30, 2024 updated by: Till Bärnighausen, University Hospital Heidelberg

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Swaziland
      • Mbabane, Swaziland
        • Clinton Health Access Initiative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care
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
Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.
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.
Experimental: CDP
Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control (continuous) among adults with diabetes
Time Frame: 12 months
Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes
12 months
Systolic blood pressure among adults with hypertension
Time Frame: 12 months
Mean systolic blood pressure among adults aged 40 years and older with hypertension
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 months
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%
12 months
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%
12 months
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
12 months
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
12 months
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
12 months
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
12 months
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
12 months
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
12 months
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
12 months
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 months
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
12 months
Diastolic blood pressure among adults with diabetes
Time Frame: 12 months
Mean diastolic blood pressure among adults aged 40 years and older with diabetes
12 months
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
12 months
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
12 months
Diastolic blood pressure among adults with hypertension
Time Frame: 12 months
Mean diastolic blood pressure among adults aged 40 years and older with hypertension
12 months
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
12 months
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
12 months
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
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Heidelberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amsterdam Institute for Global Health and Development
Swiss Tropical & Public Health Institute
University of Göttingen
Clinton Health Access Initiative, Eswatini
University of Eswatini
SWABCHA, Eswatini
Diabetes Swaziland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascal Geldsetzer, MD ScD MPH, Stanford University
  • Principal Investigator: Jan-Walter De Neve, MD ScD MPH, Heidelberg Institute of Global Health, Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WHO-PEN@Scale

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

No detailed IPD sharing plan has been developed yet.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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