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Diabetes MellitusNCT04183413

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

A study testing DSD and CDP in people with Diabetes Mellitus and Hypertension, run by University Hospital Heidelberg at 1 site in Eswatini.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Hypertension
What is being tested?
DSD and CDP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,500 participants
Where
1 siteEswatini
Study dates
1 Nov 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Eswatini1 site

  • Clinton Health Access Initiative

    Mbabane

Other trials in Eswatini

About this study

Official title: 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.

Being tested
DSD, CDP
Keywords
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
Medical subject headings
Diabetes Mellitus, Hypertension, Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSDOther

    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.

  • CDPOther

    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.

Study groups in NCT04183413
Study groupRoleWhat they receive
Standard of CareNo interventionHealth 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.
DSDExperimentalClients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.
Receives: Other: DSD
CDPExperimentalHealth services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.
Receives: Other: CDP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control (continuous) among adults with diabetes

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

    Measured: 12 months

  2. Systolic blood pressure among adults with hypertension

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

    Measured: 12 months

Secondary outcomes (21)

  1. HbA1c among adults with diabetes or prediabetes

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

    Measured: 12 months

  2. 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%

    Measured: 12 months

  3. 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%

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. 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

    Measured: 12 months

  9. 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

    Measured: 12 months

  10. 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

    Measured: 12 months

  11. Systolic blood pressure among adults with diabetes

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

    Measured: 12 months

  12. Systolic blood pressure among adults with diabetes or prediabetes

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

    Measured: 12 months

  13. Diastolic blood pressure among adults with diabetes

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

    Measured: 12 months

  14. Diastolic blood pressure among adults with diabetes or prediabetes

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

    Measured: 12 months

  15. 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

    Measured: 12 months

  16. Diastolic blood pressure among adults with hypertension

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

    Measured: 12 months

  17. 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

    Measured: 12 months

  18. 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

    Measured: 12 months

  19. 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

    Measured: 12 months

  20. 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.

    Measured: 12 months

  21. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2019
  2. Study start1 Nov 2021
  3. Primary completion5 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel three-arm cluster-randomized trial without a baseline assessment.
Masking
None (open label)
Enrolment
3,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04183413
Sponsor's protocol ID
WHO-PEN@Scale
Status last verified
Oct 2024
First submitted
22 Nov 2019
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: No detailed IPD sharing plan has been developed yet.

Publications

  • Harkare HV, Ginindza N, Stehr L, Osetinsky B, Theilmann M, Marowa LR, Ntshalintshali N, Barnighausen T, Tediosi F. Implementation of WHO-PEN interventions in Eswatini: an assessment of health equity and out-of-pocket expenditure for diabetes and hypertension care. Int J Equity Health. 2026 Mar 26;25(1):119. doi: 10.1186/s12939-026-02829-8.

    PubMed 41888803

  • Harkare HV, Osetinsky B, Ginindza N, Cindzi BT, Mncina N, Akomolafe B, Marowa LR, Ntshalintshali N, Tediosi F. Human and financial resource needs for universal access to WHO-PEN interventions for diabetes and hypertension care in Eswatini: results from a time-and-motion and bottom-up costing study. Hum Resour Health. 2024 May 27;22(1):32. doi: 10.1186/s12960-024-00913-0.

    PubMed 38802811

  • Theilmann M, Ginindza N, Myeni J, Dlamini S, Cindzi BT, Dlamini D, Dlamini TL, Greve M, Harkare HV, Hleta M, Khumalo P, Kolbe LM, Lewin S, Marowa LR, Masuku S, Mavuso D, Molemans M, Ntshalintshali N, Nxumalo N, Osetinsky B, Pell C, Reis R, Shabalala F, Simelane BR, Stehr L, Tediosi F, van Leth F, De Neve JW, Barnighausen T, Geldsetzer P. Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial. Trials. 2023 Mar 22;24(1):210. doi: 10.1186/s13063-023-07096-4.

    PubMed 36949485

Questions about this trial

What is this clinical trial studying?

A study testing DSD and CDP in people with Diabetes Mellitus and Hypertension, run by University Hospital Heidelberg at 1 site in Eswatini.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (continuous) among adults with diabetes (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04183413, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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