Community-based care for chronic diseases in rural Lesotho
Official title: Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study
Run by University Hospital, Basel, Switzerland · NCT05596773 · Data updated 2026-11-12
This study tests if community health workers in rural Lesotho can effectively help manage chronic diseases like diabetes and hypertension using new technology and regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 17500 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Maseru and 1 other locations) |
| Status | Recruiting |
| Started | February 22, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT05596773 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are residents of rural villages in Lesotho with a population of 40 to 100 households who are affected by non-communicable diseases.
✕Probably not a fit
Patients living in urban areas or those with complex chronic conditions requiring specialized medical care may not benefit from this community-based intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to evaluate the effectiveness of community-based interventions led by lay health workers for managing non-communicable diseases (NCDs) in rural Lesotho. The study will utilize eHealth tools to support Chronic Care Village Health Workers (CC-VHWs) in conducting regular screenings, monitoring, and referrals for conditions such as hypertension and diabetes. By establishing a research and service delivery platform, the study seeks to generate evidence on the impact of these interventions on chronic disease management in low-resource settings. Data will be collected by CC-VHWs who will be trained to use essential monitoring tools and eHealth applications.
Why it matters
Potential benefit: If successful, this approach could significantly improve access to chronic disease care and management in rural communities, leading to better health outcomes.
How similar studies have gone: While there is limited evidence on the effectiveness of task shifting to lay workers for NCDs in sub-Saharan Africa, similar approaches in HIV care have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria village level: * Village size of 40 to 100 households * Village consent obtained from village chief * 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 primary residence in the village (according to village chief) * Having a proven record of trustworthiness in the resident village * Having proven ability to maintain confidentiality on public matters * Being aged between 20 and 50 years * Being able to provide written reports and being able to do basic mathematical calculations * Having at least educational level equivalent to high school leaving certificate (Junior Certificate) o Additional ComBaCaL criteria: * Having the ability and willingness to work with a tablet-based eHealth tool * Having good social and communication skills * Having the ability and willingness to interact with health professionals and the village population * Being able to speak, understand and write in English- * Having successfully completed the ComBaCaL CC-VHW training including final assessment Inclusion criteria individual level: * Having primary residence in the village (self-reported at time of enrolment) * Being able and willing to consent to participation or in case of individuals aged below 18
Where it's running
-
Solidarmed Lesotho
Maseru, Lesotho Recruiting -
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Niklaus Labhardt, Prof. Dr. med. — Division of Clinical Epidemiology, University Hospital Basel, University of Basel
- Study coordinator: Niklaus Labhardt, Prof. Dr. med.
- Email: niklaus.labhardt@usb.ch
- Phone: +41 79 870 18 59
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.