Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

NCT04183413 | Completed

• 1 other identifier: WHO-PEN@Scale
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Hypertension

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• HbA1c among adults with diabetes or prediabetes

  12 months

• Glycemic control (binary) among adults with diabetes

  12 months

• Glycemic control (binary) among adults with diabetes or prediabetes

  12 months

• Awareness of one's diabetes diagnosis

  12 months

• Awareness of one's diabetes or prediabetes diagnosis

  12 months

Study Arms (3)

Standard of Care

NO INTERVENTION

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.

DSD

EXPERIMENTAL

Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.

Other: DSD

CDP

EXPERIMENTAL

Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.

Other: CDP

Interventions

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.

DSD

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.

CDP

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residing in one of the selected households
• Age ≥40 years

You may not qualify if:

• Pregnant
• Inability to provide written informed consent

Sponsors & Collaborators

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

Study Sites (1)

Clinton Health Access Initiative

Mbabane, Eswatini

Location

Related Publications (2)

• 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.

  PMID: 38802811 DERIVED

• 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.

  PMID: 36949485 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Noncommunicable Diseases

Interventions

Cytidine Diphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Pascal Geldsetzer, MD ScD MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jan-Walter De Neve, MD ScD MPH

  Heidelberg Institute of Global Health, Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Till Bärnighausen

Model Details: This is a parallel three-arm cluster-randomized trial without a baseline assessment.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2021
• Primary Completion: December 5, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

ES (1)