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

Mean HbA1c (in percent)

Change in 10-year CVD risk estimated using the World Health Organization (WHO) CVD risk prediction tool

Mean HbA1c (in percent)

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

Change in proportion of participants with an HbA1c below 8%

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

Change in number of CVD risk factors (such as smoking status, BMI, abdominal circumference, blood lipid status, blood pressure, dietary habits and physical activity)

Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment

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

Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

Number of consultations at a health facility and with the VHW

Trajectory of participants between facility-based and community-based care in the intervention villages (i.e. number of participants accepting community-based care at baseline, number of people switching to facility-based care and back to community-based care

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)

Change in proportion of participants who are reaching treatment targets (FBG <7 mmol/l) and are reporting no intake of antidiabetic medication in the two weeks prior to assessment

Change in proportion of participants accessing lipid-lowering medication

Change in health system costs for the management of participants condition

Change in individual costs for participants for the management of their condition

Change in10-year CVD risk estimated using the Globorisk score, a cardiovascular disease risk score that predicts risk of heart attack or stroke in healthy individuals for all countries in the world. It uses information on a person's country of residence, age, sex, smoking, diabetes, blood pressure and cholesterol to predict the chance that they would have a heart attack or stroke in the next 10 years.

Change in10-year CVD risk estimated using the Framingham Risk Score, a sex-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. The Framingham Risk Score was first developed based on data obtained from the Framingham Heart Study.

The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The QOL scores are summed so that a higher score indicates higher quality of life.

The BMQl comprises two 4-item factors assessing beliefs that medicines are harmful, addictive, poisons which should not be taken continuously and that medicines are overused by doctors.The items are scored on a 5 point Likert scale with scores ranging from 4 to 20.

Problem Areas in Diabetes Scale-Five-item Short Form. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.

Change in dosage of antidiabetic medications prescribed by VHWs or healthcare professionals

Change in dosage of lipid-lowering medications prescribed by VHWs or healthcare professionals