Actively Recruiting

All Genders
Healthy Volunteers
NCT05596773

Community-Based Chronic Disease Care in Rural Lesotho

Led by University Hospital, Basel, Switzerland · Updated on 2026-02-13

17500

Participants Needed

2

Research Sites

253 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

S

Swiss Agency for Development and Cooperation (SDC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Community-Based Chronic Disease Care in Rural Lesotho

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Village size of 40 to 100 households
  • Village consent obtained from village chief
  • Primary residence in the village (confirmed by village chief)
  • Proven trustworthiness in the village
  • Ability to maintain confidentiality on public matters
  • Age between 20 and 50 years
  • Ability to provide written reports and perform basic math
  • At least high school leaving certificate (Junior Certificate)
  • Ability and willingness to work with tablet-based eHealth tool
  • Good social and communication skills
  • Ability and willingness to interact with health professionals and village population
  • Ability to speak, understand, and write in English
  • Successful completion of ComBaCaL CC-VHW training including final assessment
  • At individual level, primary residence in the village (self-reported at enrollment)
  • Ability and willingness to consent to participation
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 2 locations

1

Solidarmed Lesotho

Maseru, Lesotho

Actively Recruiting

2

Division of Clinical Epidemiology, University Hospital Basel, University of Basel

Basel, Switzerland, 4001

Actively Recruiting

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Research Team

N

Niklaus Labhardt, Prof. Dr. med.

CONTACT

A

Alain Amstutz, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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