Community-based care for chronic diseases in rural Lesotho
Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study
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 |
|---|---|
| Enrollment | 17500 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Maseru and 1 other locations) |
| Trial ID | NCT05596773 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Maseru and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.