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

• ClinicalTrials.gov Identifier: NCT05743387
• Recruitment Status: Recruiting
• First Posted: February 24, 2023
• Last Update Posted: October 12, 2023
• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Agency for Development and Cooperation (SDC); World Diabetes Foundation (WDF); SolidarMed
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Tracking Information

• First Submitted Date: February 14, 2023
• First Posted Date: February 24, 2023
• Last Update Posted Date: October 12, 2023
• Actual Study Start Date: May 13, 2023
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2023)

Mean HbA1c (in percent) [ Time Frame: 12 months after enrolment ]

Mean HbA1c (in percent)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 14, 2023)

• Change in 10-year CVD risk estimated [ Time Frame: 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) [ Time Frame: 6 months after enrolment ]
  Mean HbA1c (in percent)
• Change in mean fasting blood glucose (FBG) (mmol/l) [ Time Frame: 6 and 12 months after enrolment ]
  Change in mean fasting blood glucose (FBG) (mmol/l)
• Change in proportion of participants with an HbA1c below 8% [ Time Frame: 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 [ Time Frame: 6 and 12 months after enrolment ]
  Change in proportion of participants with an FBG below 7 mmol/l
• Change in number of CVD risk factors [ Time Frame: 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)
• Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment [ Time Frame: 6 and 12 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 [ Time Frame: 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 [ Time Frame: 6 and 12 months after enrolment ]
  Change in self-reported adherence to antidiabetic medication
• Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) [ Time Frame: within 6 and 12 months after enrolment ]
  Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 14, 2023)

• Number of consultations (at a health facility and with the CC-VHW) [ Time Frame: within 6 and 12 months after enrolment ]
  Number of consultations at a health facility and with the CC-VHW
• Trajectory of participants between facility-based and community-based care in the intervention villages [ Time Frame: during the study period (up to 12 months) ]
  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 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) [ Time Frame: within 6 and 12 months after enrolment ]
  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)
• 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 [ Time Frame: 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 accessing lipid-lowering medication [ Time Frame: 6 and 12 months after enrolment ]
  Change in proportion of participants accessing lipid-lowering medication
• Change in health system costs for the management of participants condition [ Time Frame: within 6 and 12 months after diagnosis ]
  Change in health system costs for the management of participants condition
• Change in individual costs for participants for the management of their condition [ Time Frame: within 6 and 12 months after diagnosis ]
  Change in individual costs for participants for the management of their condition
• Change in10-year CVD risk estimated using the Globorisk score [ Time Frame: 6 and 12 months after enrolment ]
  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 [ Time Frame: 6 and 12 months after enrolment ]
  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.
• Quality of life (QOL) using the EQ-5D-5L instrument [ Time Frame: 12 months after enrolment ]
  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.
• Health beliefs using the Beliefs about Medicines Questionnaire (BMQ) adapted for people living with T2D [ Time Frame: 12 months after enrolment ]
  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.
• 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 [ Time Frame: 12 months after enrolment ]
  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 CC-VHWs or healthcare professionals [ Time Frame: 6 and 12 months after enrolment ]
  Change in dosage of antidiabetic medications prescribed by CC-VHWs or healthcare professionals
• Change in dosage of lipid-lowering medications prescribed by CC-VHWs or healthcare professionals [ Time Frame: 6 and 12 months after enrolment ]
  Change in dosage of lipid-lowering medications prescribed by CC-VHWs or healthcare professionals

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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)

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

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.

Primary Purpose: Health Services Research

• Condition: Type 2 Diabetes Mellitus (T2D)

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Other: T2D care package
• 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.
  Intervention: Other: Referral to the responsible health facility

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 14, 2023): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Niklaus Labhardt, Prof.; +41 79 870 18 59; niklaus.labhardt@usb.ch

Contact: Alain Amstutz, Dr.; +41 79 489 94 48; alain.amstutz@usb.ch

• Listed Location Countries: Lesotho, Switzerland

Administrative Information

• NCT Number: NCT05743387
• Other Study ID Numbers: AO_2022-00077; am23Labhardt
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current

Collaborators

• Swiss Agency for Development and Cooperation (SDC)
• World Diabetes Foundation (WDF)
• SolidarMed

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

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: October 2023