ComBaCaL: Community-Based Chronic Disease Care in Rural Lesotho

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05596773

Collaborator

Swiss Agency for Development and Cooperation (SDC) (Other), World Diabetes Foundation (WDF) (Other), SolidarMed (Other)

16,000

Enrollment

Locations

Anticipated Duration (Months)

8000

Patients Per Site

228.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-communicable Diseases (NCDs)

Detailed Description

Globally, non-communicable diseases (NCDs) are the leading cause of death and disability with a particularly high burden in Low- and middle-income countries (LMICs), where more than 75% of all premature NCD deaths occur. Lesotho is a typical example of an African LMIC where NCDs are overtaking Human immunodeficiency virus (HIV)/AIDS and other infectious diseases as major cause of disability, morbidity and early death. HIV and NCDs are chronic diseases and share several characteristics such as the asymptomatic initial phase, progression to complications with disability and early death, and need for life-long treatment. The Ministry of Health (MoH) of Lesotho has therefore proposed in its NCD strategic plan that lessons learnt from the HIV program should be taken up to similarly reduce the existing access barriers to NCD care. Two scoping reviews have shown that the evidence on how and to what extent task shifting to lay workers can successfully be implemented for NCDs in sub-Sahara Africa is very limited. This open, prospective cohort study aims at generating evidence on community-based screening, diagnosis and management of uncomplicated arterial hypertension (aHT), Diabetes mellitus (DM) and other chronic diseases by lay Village health worker (VHWs) in a rural sub-Saharan African setting. It is to establish an observational cohort (ComBaCaL cohort) with regular monitoring of chronic disease indicators and risk factors in Butha-Buthe and Mokhothlong districts in Lesotho that will be managed by lay Chronic Care Village Health Workers (CC-VHWs), supported by a dedicated tablet-based eHealth application. The prevalence of common chronic diseases and associated risk factors in the cohort population and will be assessed and their development over time will be monitored. Initial focus will be on aHT, DM, cardiovascular disease risk factors (CVDRFs) and HIV. Other conditions may be included at a later stage. The effect of the ComBaCaL activities on condition- specific care cascade outcomes, such as screening coverage, disease awareness, linkage to care, engagement in care and disease control rates will be analyzed. Cohort variables will be assessed at baseline and pre-specified analyses to assess the effect of the ComBaCaL on chronic disease care cascades will be conducted at six months (range 150-240 days) and twelve months (range 300-480 days) after enrolment. Variables which may change over time will be reassessed during follow-up visits at intervals of around six months.

The ComBaCaL cohort will be a platform for nested pragmatic trials (Trials within a Cohort, TwiCs) assessing chronic disease care interventions.

Study Design

Study Type:

Observational

Anticipated Enrollment :

16000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Screening coverage [At baseline]
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
Disease awareness [At baseline]
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
Linkage to care [Up to 3 years after enrolment]
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
Engagement in care [Up to 3 years after enrolment]
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
Disease control level [Up to 3 years after enrolment]
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)
Occurrence of clinically relevant events (number) [Up to 3 years after enrolment]
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

Other Outcome Measures

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]
Perceived appropriateness of ComBaCaL's communitybased chronic disease care activities among participants, CC-VHWs and involved healthcare professionals using mixed-methods assessments [Up to 3 years]
Number of households visited by CC-VHW [Up to 3 years]
Number of individuals monitored by one CC-VHW [Up to 3 years]
Number of individuals newly diagnosed with a chronic condition [Up to 3 years]
Number of villages inhabitants refusing community-based chronic disease screening or referral to health facility for further management after diagnosis [Up to 3 years]
Resource use of the ComBaCaL activities, including time-and-motion studies among CCVHWs [Up to 3 years]
Cost of the ComBaCaL activities, including time-and-motion studies among CCVHWs [Up to 3 years]
Completeness of the data collected by CC-VHWs [Up to 3 years]
Adherence to clinical algorithms provided via the eHealth application [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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