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ACTIVE NOT RECRUITING
NCT05743387
NA

Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO\_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs). The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho. In this DM TwiC, the effect, safety and feasibility of a community-based DM care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated DM by lay VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.

Official title: Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho Protocol for a Cluster-randomized Trial Within the ComBaCaL Cohort Study (ComBaCaL DM TwiC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2023-05-13

Completion Date

2027-12-31

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

OTHER

DM care package

DM care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated DM and treatment support and regular check-ups for complicated DM at village-level. Guidance will be provided via the CDS application. In case of complicated disease referral to the closest health facility for further management.

OTHER

Referral to the responsible health facility

VHWs will refer participants to the responsible health facility for therapeutic management. The CDS application supports clinical decision making and documentation for screening, diagnosis and referral, but not prescription/provision and monitoring of antidiabetic or lipid-lowering medication for uncomplicated DM patients or treatment support for complicated DM patients.

Locations (2)

SolidarMed Lesotho

Maseru, Lesotho

University of Basel, Division of Clinical Epidemiology

Basel, Switzerland