Type 2 Diabetes Mellitus (DM)
Conditions
Keywords
Lesotho, Southern Africa, Diabetes, Community-based care, Community Health Workers, Non-communicable diseases
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.
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 (DM) which is also the main driver of the projected increase in overall diabetes cases. The increase in DM 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 village health workers (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 Village Health Workers (VHWs) operating within the existing Ministry of Health (MoH) village health worker system will be capacitated to screen for and diagnose DM, to provide lifestyle counselling, to prescribe and to monitor first-line antidiabetic and lipid-lowering treatment for uncomplicated DM and to provide treatment support for complicated DM, supported by a tailored clinical decision support application in their villages. The control group consists of people diagnosed with DM living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where VHWs will only screen for and diagnose DM with subsequent standardized counselling and referral to the closest health facility if DM 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.
Interventions
OTHERDM care package
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.
OTHERReferral to the responsible health facility
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.
Sponsors
University Hospital, Basel, Switzerland
Swiss Agency for Development and Cooperation
The World Diabetes Foundation
SolidarMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Known type 1 diabetes mellitus * Reported pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean HbA1c (in percent) | 12 months after enrolment | Mean HbA1c (in percent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10-year CVD risk estimated | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in 10-year CVD risk estimated using the World Health Organization (WHO) CVD risk prediction tool |
| Mean HbA1c (in percent) | 6 months after enrolment | Mean HbA1c (in percent) |
| Change in mean fasting blood glucose (FBG) (mmol/l) | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in mean fasting blood glucose (FBG) (mmol/l) |
| Change in proportion of participants with an HbA1c below 8% | 6 and 12 months after enrolment | Change in proportion of participants with an HbA1c below 8% |
| Change in proportion of participants with an FBG below 7 mmol/l | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in proportion of participants with an FBG below 7 mmol/l |
| Change in number of CVD risk factors | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in number of CVD risk factors (such as smoking status, BMI, abdominal circumference, blood lipid status, blood pressure, dietary habits and physical activity) |
| Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment |
| Engagement in care: Change in proportion of participants who are engaged in care | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | 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 |
| Change in self-reported adherence to antidiabetic medication | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Change in self-reported adherence to antidiabetic medication |
| Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment | Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) |
Countries
Lesotho, Switzerland
Contacts
PRINCIPAL_INVESTIGATORNiklaus Labhardt, Prof.
Division of Clinical Epidemiology, University Hospital Basel
PRINCIPAL_INVESTIGATORAlain Amstutz, MD
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
Outcome results
None listed