Clinical trial NCT05743387: Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2D)
Keywords: 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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Agency for Development and Cooperation (SDC)
name: World Diabetes Foundation (WDF)
name: SolidarMed
First posted: 2023-02-24
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean HbA1c (in percent)
timeFrame: 12 months after enrolment
Secondary outcomes:
measure: Change in 10-year CVD risk estimated
timeFrame: 6 and 12 months after enrolment
measure: Mean HbA1c (in percent)
timeFrame: 6 months after enrolment
measure: Change in mean fasting blood glucose (FBG) (mmol/l)
timeFrame: 6 and 12 months after enrolment
measure: Change in proportion of participants with an HbA1c below 8%
timeFrame: 6 and 12 months after enrolment
measure: Change in proportion of participants with an FBG below 7 mmol/l
timeFrame: 6 and 12 months after enrolment
measure: Change in number of CVD risk factors
timeFrame: 6 and 12 months after enrolment
measure: Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment
timeFrame: 6 and 12 months after enrolment
measure: Engagement in care: Change in proportion of participants who are engaged in care
timeFrame: 6 and 12 months after enrolment
measure: Change in self-reported adherence to antidiabetic medication
timeFrame: 6 and 12 months after enrolment
measure: Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: within 6 and 12 months after enrolment
Other outcomes:
measure: Number of consultations (at a health facility and with the CC-VHW)
timeFrame: within 6 and 12 months after enrolment
measure: Trajectory of participants between facility-based and community-based care in the intervention villages
timeFrame: during the study period (up to 12 months)
measure: 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)
timeFrame: within 6 and 12 months after enrolment
measure: 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
timeFrame: 6 and 12 months after enrolment
measure: Change in proportion of participants accessing lipid-lowering medication
timeFrame: 6 and 12 months after enrolment
measure: Change in health system costs for the management of participants condition
timeFrame: within 6 and 12 months after diagnosis
measure: Change in individual costs for participants for the management of their condition
timeFrame: within 6 and 12 months after diagnosis
measure: Change in10-year CVD risk estimated using the Globorisk score
timeFrame: 6 and 12 months after enrolment
measure: Change in10-year CVD risk estimated using the Framingham Risk Score
timeFrame: 6 and 12 months after enrolment
measure: Quality of life (QOL) using the EQ-5D-5L instrument
timeFrame: 12 months after enrolment
measure: Health beliefs using the Beliefs about Medicines Questionnaire (BMQ) adapted for people living with T2D
timeFrame: 12 months after enrolment
measure: 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
timeFrame: 12 months after enrolment
measure: Change in dosage of antidiabetic medications prescribed by CC-VHWs or healthcare professionals
timeFrame: 6 and 12 months after enrolment
measure: Change in dosage of lipid-lowering medications prescribed by CC-VHWs or healthcare professionals
timeFrame: 6 and 12 months after enrolment
Locations:
city: Maseru
country: Lesotho
facility: SolidarMed Lesotho
city: Basel
country: Switzerland
facility: University of Basel, Division of Clinical Epidemiology
Study officials:
affiliation: Division of Clinical Epidemiology, University Hospital Basel
name: Niklaus Labhardt, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Clinical Epidemiology, University Hospital Basel, University of Basel
name: Alain Amstutz, MD
role: PRINCIPAL_INVESTIGATOR
References: