Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho
- Conditions
- Type 2 Diabetes Mellitus (T2D)
- Interventions
- Other: T2D care packageOther: Referral to the responsible health facility
- Registration Number
- NCT05743387
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- Known type 1 diabetes mellitus
- Reported pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention villages T2D care package 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. Control villages Referral to the responsible health facility In control villages, CC-VHWs will refer participants to the responsible health facility for therapeutic management after enrolment and baseline assessment.
- Primary Outcome Measures
Name Time Method Mean HbA1c (in percent) 12 months after enrolment Mean HbA1c (in percent)
- Secondary Outcome Measures
Name Time Method Change in proportion of participants with an FBG below 7 mmol/l 6 and 12 months after enrolment Change in proportion of participants with an FBG below 7 mmol/l
Change in 10-year CVD risk estimated 6 and 12 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 and 12 months after enrolment Change in mean fasting blood glucose (FBG) (mmol/l)
Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment 6 and 12 months after enrolment Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment
Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) within 6 and 12 months after enrolment Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
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 number of CVD risk factors 6 and 12 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)
Engagement in care: Change in proportion of participants who are engaged in care 6 and 12 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 and 12 months after enrolment Change in self-reported adherence to antidiabetic medication
Trial Locations
- Locations (2)
University of Basel, Division of Clinical Epidemiology
🇨🇭Basel, Switzerland
SolidarMed Lesotho
🇱🇸Maseru, Lesotho