NCT05596773Recruiting
Community-Based Chronic Disease Care in Rural Lesotho
Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 17500 (estimated)
- First submitted
- 12 Oct 2022
- Start date
- 22 Feb 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- High blood pressure
- NCT number
- NCT05596773
What you commit to
- Study type: Observational
- Planned participants: 17500
- From 22 Feb 2023 to the primary completion date, 31 Dec 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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
Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Clinical Epidemiology, University Hospital Basel, University of Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Solidarmed Lesotho Coordinator of this site? Confirm its status | Maseru | Lesotho | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.