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NCT04183413

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Completed NA Last updated 31 October 2024
What this trial tests

NA trial testing DSD in Diabetes Mellitus in 3,500 participants. Completed in 31 December 2023.

Timeline
1 November 2021
Primary endpoint
5 December 2023
31 December 2023

Quick facts

Lead sponsorUniversity Hospital Heidelberg
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment3,500
Start date1 November 2021
Primary completion5 December 2023
Estimated completion31 December 2023
Sites1 location across Eswatini

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Heidelberg

Who can join

40 and older, any sex, with Diabetes Mellitus or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial.
    Theilmann M, Ginindza N, Myeni J, Dlamini S, et al · · 2023 · cited 3× · PMID 36949485 · DOI 10.1186/s13063-023-07096-4
  2. 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.
    Harkare HV, Osetinsky B, Ginindza N, Cindzi BT, et al · · 2024 · cited 1× · PMID 38802811 · DOI 10.1186/s12960-024-00913-0
  3. Implementation of WHO-PEN interventions in Eswatini: an assessment of health equity and out-of-pocket expenditure for diabetes and hypertension care.
    Harkare HV, Ginindza N, Stehr L, Osetinsky B, et al · · 2026 · PMID 41888803 · DOI 10.1186/s12939-026-02829-8

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

Other University Hospital Heidelberg trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing