NCT05743387

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 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2023Dec 2027

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2025

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

February 14, 2023

Last Update Submit

September 7, 2026

Conditions

Type 2 Diabetes Mellitus (DM)

Keywords

LesothoSouthern AfricaDiabetesCommunity-based careCommunity Health WorkersNon-communicable diseases

Outcome Measures

Primary Outcomes (1)

  • Mean HbA1c (in percent)

    Mean HbA1c (in percent)

    12 months after enrolment

Secondary Outcomes (10)

  • Change in 10-year CVD risk estimated

    6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment

  • Mean HbA1c (in percent)

    6 months after enrolment

  • Change in mean fasting blood glucose (FBG) (mmol/l)

    6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment

  • Change in proportion of participants with an HbA1c below 8%

    6 and 12 months after enrolment

  • Change in proportion of participants with an FBG below 7 mmol/l

    6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment

  • +5 more secondary outcomes

Other Outcomes (14)

  • Number of consultations (at a health facility and with the VHW)

    within 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment

  • Trajectory of participants between facility-based and community-based care in the intervention villages

    during the study period (up to 48 months)

  • Proportion of participants with DM who stop drug treatment or interrupt drug treatment for more than three weeks or require a switch of drug treatment due to (perceived) adverse events (AEs)

    within 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment

  • +11 more other outcomes

Study Arms (2)

Intervention villages

ACTIVE COMPARATOR

In the intervention villages, VHWs will offer * a 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 according to clinical algorithms based on international guidelines for primary healthcare management of DM and the updated Lesotho Standard Treatment Guidelines. * Direct guidance for treatment initiation, drug prescription, counselling and monitoring will be provided via the CDS application. * 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.

Other: DM care package

Control villages

ACTIVE COMPARATOR

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

Other: Referral to the responsible health facility

Interventions

Referral to the responsible health facilityOTHER

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.

Control villages
DM care packageOTHER

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.

Intervention villages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known type 1 diabetes mellitus
  • Reported pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SolidarMed Lesotho

Maseru, Lesotho

Location

University of Basel, Division of Clinical Epidemiology

Basel, 4051, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 37875943BACKGROUND

  • Gerber F, Gupta R, Sanchez-Samaniego G, Lejone TI, Tahirsylaj T, Raeber F, Saavedra EB, Esquivel-Valdes I, Chitja M, Molulela M, Khomolishoele M, Mota M, Bane M, Masike S, Sematle MP, Mofokeng M, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Seelig E, Chammartin F, Labhardt ND, Amstutz A. Community health worker-led versus facility-based type 2 diabetes care in rural Lesotho: a cluster-randomized trial within the ComBaCaL cohort study. BMC Med. 2026 May 22;24(1):400. doi: 10.1186/s12916-026-04943-4.

    PMID: 42174613DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Niklaus Labhardt, Prof.

    Division of Clinical Epidemiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

  • Alain Amstutz, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants are not blinded to the intervention due to the nature of the intervention. Due to the cluster level randomization and TwiCs approach participants are blinded to the allocation (i.e. participants in the control villages are not aware of the intervention being implemented in the intervention villages). The main outcome and the safety endpoints are assessed by an independent study physician blinded to the allocation. The statistician and data managers cannot be blinded to the allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trial nested within the ComBaCaL cohort study following a trial within cohort (TwiC) approach. 50% of the villages being part of the overarching ComBaCaL cohort will be randomized stratified by district and access to health facility to receive the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

May 13, 2023

Primary Completion

March 23, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

* An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium. * The statistical report for the primary and key secondary endpoints and the code to produce it will be published together with the data set.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
• Within 3 months after publication of primary results
Access Criteria
• Open access

Locations

CH(1)LE(1)