Community-Based Chronic Disease Care in Rural Lesotho

NCT05596773 | Recruiting

• 1 other identifier: AO_2022-00058; ex21Labhardt
• Study Type: observational
• Target: 17,500
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Non-communicable Diseases (NCDs)

Keywords

Community-Based Chronic Disease Care Lesotho (ComBaCaL); Chronic Care Village Health Worker (CC-VHWs); eHealth application (ComBaCaL app); Lesotho; low- and middle-income countries (LMICs); Arterial hypertension (aHT); Diabetes mellitus (DM)

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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)

  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

  Up to 3 years after enrolment

Other Outcomes (12)

• Feasibility of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments

  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

  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

  Up to 3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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-

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• World Diabetes Foundation (WDF): collaborator
• Swiss Agency for Development and Cooperation (SDC): collaborator
• SolidarMed: collaborator

Study Sites (2)

Solidarmed Lesotho

Maseru, Lesotho

RECRUITING

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

Basel, 4001, Switzerland

RECRUITING

Related Publications (1)

• Gerber F, Sanchez-Samaniego G, Tahirsylaj T, Lejone TI, Lee T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Mota M, Masike S, Bane M, Makabateng R, Khomolishoele M, Sematle M, Gupta R, Ayakaka I, Sao L, Tlahali M, Phaaroe S, Litaba M, Mphunyane M, Basler DB, Kindler K, Grimm P, Seelig E, Burkard T, Briel M, Chammartin F, Amstutz A, Labhardt ND. Cohort profile: the open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort - design, baseline chronic disease risk factors and hypertension and diabetes care cascades. BMJ Open. 2025 Jul 25;15(7):e093852. doi: 10.1136/bmjopen-2024-093852.

  PMID: 40713039 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma or dried blood spot samples of cohort participants may be collected for storage and future analysis. No human genome analysis will be conducted on the samples collected.

MeSH Terms

Conditions

Noncommunicable Diseases; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Niklaus Labhardt, Prof. Dr. med.

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

  PRINCIPAL INVESTIGATOR

• Alain Amstutz, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklaus Labhardt, Prof. Dr. med.

CONTACT

+41 79 870 18 59; niklaus.labhardt@usb.ch

Alain Amstutz, MD

CONTACT

+41 79 489 94 48; alain.amstutz@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 27, 2022
• Study Start: February 22, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: • Within 3 months after publication of primary results
• Access Criteria: • Open access

Locations

LE (1); CH (1)