An observational study in Non-communicable Diseases (NCDs), sponsored by University Hospital, Basel, Switzerland. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University Hospital, Basel, Switzerland · Observational
This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs) providing regular chronic disease screening, monitoring and referral services. The implementation outcomes of the cohort as well as the effect of the cohort activities on disease-specific care cascades will be assessed. Subsequently, nested trials to assess the effectiveness of specific chronic disease control interventions will be developed. Measurements and data entry will be conducted by CC-VHWs. The CC-VHWs will be equipped with the essential tools required for chronic disease monitoring in the community (i.e. BP machines, scales, measuring band, glucometers, and urine dipsticks). They will undergo a theoretical and practical training covering all aspects required for correct data collection and chronic disease screening, diagnosing, referral and counselling services. At every visit, the CC-VHW will screen participants for warning signs and symptoms (i.e. shortness of breath, severe headache, chest pain, new-onset confusion, impaired consciousness, severely impaired general state of health) and refer participants to the closest health centre in case of any danger-sign. The CC-VHWs will be continuously monitored and supervised by health centre nurses of the respective village's catchment area, mainly through direct interaction during monthly VHW meetings and by CC nurses through field visits, remote interaction via phone calls or messages sent via the ComBaCaL app and through direct contact during the monthly VHW meetings at the health centre. The CC-VHWs are embedded within the Lesotho MoH VHW program and may during the project period be trained and equipped to provide further routine services in their communities.
Globally, non-communicable diseases (NCDs) are the leading cause of death and disability with a particularly high burden in Low- and middle-income countries (LMICs), where more than 75% of all premature NCD deaths occur. Lesotho is a typical example of an African LMIC where NCDs are overtaking Human immunodeficiency virus (HIV)/AIDS and other infectious diseases as major cause of disability, morbidity and early death. HIV and NCDs are chronic diseases and share several characteristics such as the asymptomatic initial phase, progression to complications with disability and early death, and need for life-long treatment. The Ministry of Health (MoH) of Lesotho has therefore proposed in its NCD strategic plan that lessons learnt from the HIV program should be taken up to similarly reduce the existing access barriers to NCD care. Two scoping reviews have shown that the evidence on how and to what extent task shifting to lay workers can successfully be implemented for NCDs in sub-Sahara Africa is very limited. This open, prospective cohort study aims at generating evidence on community-based screening, diagnosis and management of uncomplicated arterial hypertension (aHT), Diabetes mellitus (DM) and other chronic diseases by lay Village health worker (VHWs) in a rural sub-Saharan African setting. It is to establish an observational cohort (ComBaCaL cohort) with regular monitoring of chronic disease indicators and risk factors in Butha-Buthe and Mokhothlong districts in Lesotho that will be managed by lay Chronic Care Village Health Workers (CC-VHWs), supported by a dedicated tablet-based eHealth application. The prevalence of common chronic diseases and associated risk factors in the cohort population and will be assessed and their development over time will be monitored. Initial focus will be on aHT, DM, cardiovascular disease risk factors (CVDRFs) and HIV. Other conditions may be included at a later stage. The effect of the ComBaCaL activities on condition- specific care cascade outcomes, such as screening coverage, disease awareness, linkage to care, engagement in care and disease control rates will be analyzed. Cohort variables will be assessed at baseline and pre-specified analyses to assess the effect of the ComBaCaL on chronic disease care cascades will be conducted at six months (range 150-240 days) and twelve months (range 300-480 days) after enrolment. Variables which may change over time will be reassessed during follow-up visits at intervals of around six months.
The ComBaCaL cohort will be a platform for nested pragmatic trials (Trials within a Cohort, TwiCs) assessing chronic disease care interventions.
144 studies on the registry are indexed under Noncommunicable Diseases; 55 are open to participants now.
This study's planned enrollment of 17,500 is above the median of 1,674 across 48 observational studies indexed under Noncommunicable Diseases.
Browse Noncommunicable Diseases studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inhabitants of around 100 (range 90-110) randomly selected villages in rural Lesotho. The estimated mean number of inhabitants per village is 200. All inhabitants will be approached for consent and all consenting individuals (assent plus guardian consent for adolescents (10-17 years), guardian consent for children \<10 years) will be enrolled into the ComBaCaL cohort.
Inclusion Criteria village level:
Possibility to identify or recruit a CC-VHW from the village population meeting the following requirements which are largely in line with the criteria of the Lesotho VHW Program Policy:
o Criteria of the Lesotho Village Health Program Policy:
Having at least educational level equivalent to high school leaving certificate (Junior Certificate)
o Additional ComBaCaL criteria:
Inclusion criteria individual level:
Screening coverage
Screening coverage for aHT and (pre)DM, defined as the proportion of screening-eligible participants that have been screened for the respective disease within the previous 3 years
Time frame: At baseline
Disease awareness
Disease awareness for aHT and (pre)DM, defined as the proportion of participants diagnosed with aHT or (pre)DM that are aware of their condition
Time frame: At baseline
Linkage to care
Linkage to care for aHT and DM, defined as the number of participants with aHT or (pre)DM who (re)started drug treatment for their respective condition since enrolment
Time frame: Up to 3 years after enrolment
Engagement in care
Engagement in care for aHT and DM, defined as the number of participants with aHT or (pre)DM who had a check-up measurement (BG or HbA1C for (pre)DM, BP for aHT) or drug refill within the last 180 days for their condition
Time frame: Up to 3 years after enrolment
Disease control level
Disease control level for aHT and DM, defined as the number of participants with aHT or DM who are reaching disease-specific treatment targets (BP \<140/90 mmHg for aHT, fasting blood glucose (FBG) \< 7mmol/l and/or HbA1C \<7.0% for DM)
Time frame: Up to 3 years after enrolment
Occurrence of clinically relevant events (number)
Occurrence of clinically relevant events (Clinical event of special interest (CESI), Serious clinical event (SCE), Serious clinical event of special interest (SCESI), as defined by the protocol
Time frame: Up to 3 years after enrolment
Feasibility of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments
Time frame: Up to 3 years
Acceptability of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments
Time frame: Up to 3 years
Satisfaction of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments
Time frame: Up to 3 years
Perceived appropriateness of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments
Time frame: Up to 3 years
Number of households visited by CC-VHW
Time frame: Up to 3 years
Number of individuals monitored by one CC-VHW
Time frame: Up to 3 years
Number of individuals newly diagnosed with a chronic condition
Time frame: Up to 3 years
Number of villages inhabitants refusing community-based chronic disease screening or referral to health facility for further management after diagnosis
Time frame: Up to 3 years
Resource use of the ComBaCaL activities, including time-and-motion studies among CCVHWs
Time frame: Up to 3 years
Cost of the ComBaCaL activities, including time-and-motion studies among CCVHWs
Time frame: Up to 3 years
Completeness of the data collected by CC-VHWs
Time frame: Up to 3 years
Adherence to clinical algorithms provided via the eHealth application
Time frame: Up to 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — An anonymized key dataset will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Within 3 months after publication of primary results
Access criteria: Open access
Started Feb 2023 (actual). Primary completion is estimated for Dec 2027, 58 months after the start.
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