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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 T2D TwiC)

Conditions
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Type 2 Diabetes Mellitus (T2D)

Intervention / Treatment
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* Other: T2D care package
* Other: Referral to the responsible health facility


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention villages<br>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<br>* 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.<br>|
| Active Comparator: Control villages<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean HbA1c (in percent) | Mean HbA1c (in percent) | 12 months after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-year CVD risk estimated | Change in 10-year CVD risk estimated using the World Health Organization (WHO) CVD risk prediction tool | 6 and 12 months after enrolment | 
| Mean HbA1c (in percent) | Mean HbA1c (in percent) | 6 months after enrolment | 
| Change in mean fasting blood glucose (FBG) (mmol/l) | 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% | 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 | Change in proportion of participants with an FBG below 7 mmol/l | 6 and 12 months after enrolment | 
| Change in number of CVD risk factors | Change in number of CVD risk factors (such as smoking status, BMI, abdominal circumference, blood lipid status, blood pressure, dietary habits and physical activity) | 6 and 12 months after enrolment | 
| Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment | Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment | 6 and 12 months after enrolment | 
| Engagement in care: Change in proportion of participants who are engaged in care | Change in proportion of participants who are engaged in care, defined as reporting intake of antidiabetic medication as per prescription of a healthcare provider or reaching treatment targets without intake of medication | 6 and 12 months after enrolment | 
| Change in self-reported adherence to antidiabetic medication | Change in self-reported adherence to antidiabetic medication | 6 and 12 months after enrolment | 
| Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | within 6 and 12 months after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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