Type 2 Diabetes Mellitus (T2D) Clinical Trial
— ComBaCaL T2DOfficial 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)
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Lesotho | SolidarMed Lesotho | Maseru | |
| Switzerland | University of Basel, Division of Clinical Epidemiology | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | SolidarMed, Swiss Agency for Development and Cooperation (SDC), World Diabetes Foundation (WDF) |
Lesotho, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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) | |
| Other | 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 | |
| Other | 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 | |
| Other | Change in proportion of participants accessing lipid-lowering medication | Change in proportion of participants accessing lipid-lowering medication | 6 and 12 months after enrolment | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Primary | Mean HbA1c (in percent) | Mean HbA1c (in percent) | 12 months after enrolment | |
| Secondary | 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 | |
| Secondary | Mean HbA1c (in percent) | Mean HbA1c (in percent) | 6 months after enrolment | |
| Secondary | Change in mean fasting blood glucose (FBG) (mmol/l) | Change in mean fasting blood glucose (FBG) (mmol/l) | 6 and 12 months after enrolment | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Change in self-reported adherence to antidiabetic medication | Change in self-reported adherence to antidiabetic medication | 6 and 12 months after enrolment | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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