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

NCT ID: NCT05743387

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-13
• Study Completion Date: 2026-05-31

Brief 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.

Detailed Description

Globally, 9.3% of the adult population or 436 million individuals were estimated to be living with diabetes in 2019. Until 2045 this number is expected to increase by more than 50% to over 700 million. Four out of five people affected by diabetes are currently living in low- and middle-income countries (LMICs). Over 90% of all diabetes cases are due to type 2 diabetes (T2D) which is also the main driver of the projected increase in overall diabetes cases. The increase in T2D prevalence is caused by ageing populations and changing lifestyles with decreasing levels of physical activity and higher caloric diets and associated obesity.

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).

In this trial, using the Trials within Cohorts (TwiCs) approach, it will be analyzed whether an LHW-led model could be capacitated to safely and effectively provide first-line management (including oral antidiabetic, lipid-lowering treatment and lifestyle counselling) at community-level.

In villages randomized to the intervention arm, lay Chronic Care Village Health Workers (CCVHWs) operating within the existing Ministry of Health (MoH) village health worker system will be capacitated to screen for and diagnose T2D, to provide lifestyle counselling, to prescribe and to monitor first-line antidiabetic and lipid-lowering treatment for uncomplicated T2D and to provide treatment support for complicated T2D, supported by a tailored clinical decision support application (ComBaCaL app) in their villages.

The control group consists of people diagnosed with T2D living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where CC-VHWs will only screen for and diagnose T2D with subsequent standardized counselling and referral to the closest health facility if T2D is present, but no village-based prescriptions. 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.

Conditions

Type 2 Diabetes Mellitus (T2D)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention villages

In the intervention villages, CC-VHWs will offer

• a 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 according to clinical algorithms based on international guidelines for primary healthcare management of T2D and the updated Lesotho Standard Treatment Guidelines.
• Direct guidance for treatment initiation, drug prescription, counselling and monitoring will be provided via the ComBaCaL app.
• In case of complicated disease (i.e. if treatment targets are not reached with metformin alone), unclear diagnosis, relevant comorbidities or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further management.

Group Type: ACTIVE_COMPARATOR

T2D care package

Intervention Type: OTHER

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.

Control villages

In control villages, CC-VHWs will refer participants to the responsible health facility for therapeutic management after enrolment and baseline assessment.

Group Type: ACTIVE_COMPARATOR

Referral to the responsible health facility

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant of the ComBaCaL cohort study (signed informed consent available)
• Living with T2D, defined as reporting intake of antidiabetic medication or being newly diagnosed during screening via standard diagnostic algorithm

Exclusion Criteria

• Known type 1 diabetes mellitus
• Reported pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Agency for Development and Cooperation (SDC)

UNKNOWN

Sponsor Role: collaborator

World Diabetes Foundation (WDF)

UNKNOWN

Sponsor Role: collaborator

SolidarMed

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niklaus Labhardt, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Epidemiology, University Hospital Basel

Alain Amstutz, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Epidemiology, University Hospital Basel, University of Basel

Locations

SolidarMed Lesotho

Maseru, , Lesotho

University of Basel, Division of Clinical Epidemiology

Basel, , Switzerland

Countries

Lesotho; Switzerland

References

Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Kohler M, Haldemann MI, Raber F, Chitja M, Manthabiseng M, Khomolishoele M, Mota M, Bane M, Sematle PM, Makabateng R, Mphunyane M, Phaaroe S, Basler D, Kindler K, Seelig E, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC). Trials. 2023 Oct 24;24(1):688. doi: 10.1186/s13063-023-07729-8.

Reference Type: DERIVED

PMID: 37875943 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Protocol

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan

View Document

Other Identifiers

AO_2022-00077; am23Labhardt

Identifier Type: -

Identifier Source: org_study_id