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

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 chronic care village health workers (CC-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 T2D TwiC, the effect, safety and feasibility of a community-based T2D care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated T2D by lay CC-VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.

Conditions

• Type 2 Diabetes Mellitus (T2D)

Interventions

OTHER

T2D care package

T2D care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated T2D and treatment support and regular check-ups for complicated T2D at village-level. Guidance will be provided via the ComBaCaL app. In case of complicated disease referral to the closest health facility for further management.

OTHER

Referral to the responsible health facility

CC-VHWs will refer participants to the responsible health facility for therapeutic management. The ComBaCaL app 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 T2D patients or treatment support for complicated T2D patients.

Sponsors & Collaborators

• Swiss Agency for Development and Cooperation (SDC)

  collaborator UNKNOWN

• World Diabetes Foundation (WDF)

  collaborator UNKNOWN

• SolidarMed

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Niklaus Labhardt, Prof. · Division of Clinical Epidemiology, University Hospital Basel

• Alain Amstutz, MD · Division of Clinical Epidemiology, University Hospital Basel, University of Basel

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-13

Primary Completion

2025-03-23

Completion

2027-12-31

Countries

• Lesotho
• Switzerland

Study Locations