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

NCT05743387 | Active Not Recruiting

• 1 other identifier: AO_2022-00077; am23Labhardt
• Study Type: interventional
• Target: 252
• Locations: 2 countries
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus (T2D)

Keywords

Community-Based Chronic Disease Care Lesotho (ComBaCaL) cohort study; low- and middle-income countries (LMICs); lay healthcare worker (LHW); chronic care village health worker (CC-VHW); chronic care nurse (CC nurse); non-communicable disease (NCD); blood glucose (BG); cardiovascular disease risk factor (CVDRF); glycated haemoglobin (HbA1c); Lesotho Ministry of Health (MoH) Village Health Worker Program; first-line antidiabetics; first-line lipid-lowering treatment

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 and 12 months after enrolment

• Mean HbA1c (in percent)

  6 months after enrolment

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

  6 and 12 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 and 12 months after enrolment

Other Outcomes (14)

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

  within 6 and 12 months after enrolment

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

  during the study period (up to 12 months)

• Proportion of participants with T2D 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 and 12 months after enrolment

Study Arms (2)

Intervention villages

ACTIVE COMPARATOR

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.

Other: T2D care package

Control villages

ACTIVE COMPARATOR

In control villages, CC-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

T2D care package 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.

Intervention villages

Referral to the responsible health facility 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.

Control villages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known type 1 diabetes mellitus
• Reported pregnancy

Sponsors & Collaborators

• SolidarMed: collaborator
• University Hospital, Basel, Switzerland: lead
• Swiss Agency for Development and Cooperation (SDC): collaborator
• World Diabetes Foundation (WDF): collaborator

Study Sites (2)

SolidarMed Lesotho

Maseru, Lesotho

Location

University of Basel, Division of Clinical Epidemiology

Basel, 4051, Switzerland

Location

Related Publications (1)

• 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: 37875943 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological 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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

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: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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)