Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho (ComBaCaL T2D)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2D)
• Intervention / Treatment: Other: T2D care package; Other: Referral to the responsible health facility

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niklaus Labhardt, Prof.; Phone Number: +41 79 870 18 59; Email: niklaus.labhardt@usb.ch
• Study Contact Backup: Name: Alain Amstutz, Dr.; Phone Number: +41 79 489 94 48; Email: alain.amstutz@usb.ch

Study Locations

• Lesotho
  • Maseru, Lesotho
    • Recruiting
    • Solidarmed Lesotho
    • Contact: Irene Ayakaka, MD; Phone Number: +266 28325172; Email: ayakaka@gmail.com
    • Principal Investigator: Irene Ayakaka, MD
    • Sub-Investigator: Mamakhala Chitja, MBBS
    • Sub-Investigator: Ravi Gupta, MBBS
• Switzerland
  • Basel, Switzerland, 4051
    • Recruiting
    • University of Basel, Division of Clinical Epidemiology
    • Contact: Niklaus Labhardt, Prof.; Phone Number: +41 79 870 18 59; Email: niklaus.labhardt@usb.ch
    • Contact: Felix Gerber; Phone Number: +41 78 704 08 85; Email: felix.gerber@usb.ch
    • Principal Investigator: Niklaus Labhardt, Prof.
    • Principal Investigator: Alain Amstutz, MD
    • Sub-Investigator: Felix Gerber
    • Sub-Investigator: Thabo Lejone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention villages; 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; 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.
Active Comparator: Control villages; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of consultations (at a health facility and with the CC-VHW)	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	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	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)	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
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 who are reaching treatment targets (FBG <7 mmol/l) and are reporting no intake of antidiabetic medication in the two weeks prior to assessment	6 and 12 months after enrolment
Change in proportion of participants accessing lipid-lowering medication	Change in proportion of participants accessing lipid-lowering medication	6 and 12 months after enrolment
Change in health system costs for the management of participants condition	Change in health system costs for the management of participants condition	within 6 and 12 months after diagnosis
Change in individual costs for participants for the management of their condition	Change in individual costs for participants for the management of their condition	within 6 and 12 months after diagnosis
Change in10-year CVD risk estimated using the Globorisk score	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.	6 and 12 months after enrolment
Change in10-year CVD risk estimated using the Framingham Risk Score	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.	6 and 12 months after enrolment
Quality of life (QOL) using the EQ-5D-5L instrument	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.	12 months after enrolment
Health beliefs using the Beliefs about Medicines Questionnaire (BMQ) adapted for people living with T2D	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.	12 months after enrolment
Diabetes distress using the five item version of the "Problem Areas in Diabetes" (PAID-5) scale Problem Areas in Diabetes Scale-Five-item Short Form	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.	12 months after enrolment
Change in dosage of antidiabetic medications prescribed by CC-VHWs or healthcare professionals	Change in dosage of antidiabetic medications prescribed by CC-VHWs or healthcare professionals	6 and 12 months after enrolment
Change in dosage of lipid-lowering medications prescribed by CC-VHWs or healthcare professionals	Change in dosage of lipid-lowering medications prescribed by CC-VHWs or healthcare professionals	6 and 12 months after enrolment

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: SolidarMed; Swiss Agency for Development and Cooperation (SDC); World Diabetes Foundation (WDF)
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: low- and middle-income countries (LMICs); Community-Based Chronic Disease Care Lesotho (ComBaCaL) cohort study; Lesotho Ministry of Health (MoH) Village Health Worker Program; glycated haemoglobin (HbA1c); 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); first-line antidiabetics; first-line lipid-lowering treatment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AO_2022-00077; am23Labhardt

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No