Clinical trial NCT05684055: "Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)
Official title: Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers for People With Controlled and Uncontrolled Arterial Hypertension in Rural Lesotho: Joint Protocol for Two Cluster-randomized Trials Within the ComBaCaL Cohort Study (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arterial Hypertension
Keywords: Community-Based Chronic Disease Care Lesotho (ComBaCaL) cohort study
low- and middle-income countries (LMICs)
facility-based healthcare professionals
lay healthcare workers (LHWs)
community-based aHT care models
chronic care village health workers (CC-VHWs)
Lesotho Ministry of Health (MoH) Village Health Worker Program
village-based prescription
chronic care nurses (CC nurses)
non-communicable diseases (NCDs)
cardiovascular disease (CVD)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Agency for Development and Cooperation (SDC)
name: World Diabetes Foundation (WDF)
First posted: 2023-01-13
Enrollment: 1352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization for the two TwiCs will be done at cluster level, meaning that all people with aHT in one village will be offered the same care package from their local CC-VHW.

ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints. They only differ in the trial population and trial hypothesis. TwiC 1 enrols individuals with uncomplicated aHT with baseline BP values above treatment targets. TwiC 2 enrols individuals with uncomplicated pharmacologically controlled aHT. In the intervention clusters community-based treatment is offered. In the control clusters participants are referred to the facility for further care after diagnosis.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints. TwiC 1 enrols individuals with uncomplicated aHT with baseline BP values above treatment targets and the hypothesis is that in intervention clusters where community-based treatment is offered, a higher proportion will have controlled aHT at twelve months' follow-up as compared to control clusters where participants are referred to the facility for further care after diagnosis.

TwiC 2 enrols individuals with uncomplicated pharmacologically controlled aHT with the hypothesis that the offer of community-based antihypertensive treatment is non-inferior to facility-based care with regard to BP control rates at twelve months. The trials are nested within the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID 2022-00058, clinicaltrials.gov ID NCT05596773), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local chronic care village health workers (CC-VHWs). 50% of the villages being part of the overarching ComBaCaL cohort will be randomly allocated to receive the TwiC intervention. The non-selected villages will serve as comparators and follow the regular ComBaCaL cohort activities conducted by CC-VHWs, including screening, diagnosis, standardized counselling and referral to a health facility for further therapeutic management. The TwiC intervention will be offered to all eligible people living with aHT in the sampled intervention villages. Individuals with uncomplicated uncontrolled and uncomplicated controlled aHT at baseline will be enrolled in aHT TwiC 1 and aHT 2 respectively. In case of complicated disease, unclear diagnosis, or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further investigation.

Detailed description: Globally, arterial hypertension (aHT) is the single most important risk factor for early mortality. The task-shifting from facility-based healthcare professionals to lay healthcare workers (LHWs) at community-level has been identified as a promising solution to increase access to aHT treatment in low- and middle-income countries (LMICs). A cluster-randomized intervention is planned within the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID 2022-00058, clinicaltrials.gov ID NCT05596773), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local chronic care village health workers (CC-VHWs). CC-VHWs are lay healthcare workers operating within the Lesotho Ministry of Health (MoH) Village Health Worker Program who receive a specific training to deliver chronic care services.

In the intervention clusters, CC-VHWs operating within the existing healthcare system will be capacitated to screen for and diagnose aHT, to prescribe first-line antihypertensive single-pill combinations (SPCs) and to monitor the treatment supported by a tailored clinical decision support application (ComBaCaL app) in their villages. The control group consists of people diagnosed with aHT living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where CC-VHWs will only screen for and diagnose aHT with subsequent standardized counselling and referral to the closest health facility if aHT is present, but no village-based prescriptions.

The effectiveness of this intervention in two different trial populations is assessed:

* in people with uncomplicated aHT and blood pressure (BP) values above treatment target (≥ 140/90 mmHg) at baseline (aHT TwiC 1) and
* in people with uncomplicated aHT and BP values below treatment target at baseline (aHT TwiC 2).

Randomization for the two TwiCs will be done at cluster level, meaning that all people with aHT in one village will be offered the same care package from their local CC-VHW. It is planned to recruit 100 clusters (50 per study arm) for a total of 800 participants with uncontrolled aHT (TwiC 1) and 1000 participants with controlled aHT (TwiC2). 50% of the villages being part of the overarching ComBaCaL cohort will be randomly allocated to receive the TwiC intervention. The non-selected villages will serve as comparators and follow the regular ComBaCaL cohort activities conducted by CC-VHWs, including screening, diagnosis, standardized counselling and referral to a health facility for further therapeutic management. The TwiC intervention will be offered to all eligible people living with aHT in the sampled intervention villages. Individuals with uncomplicated uncontrolled and uncomplicated controlled aHT at baseline will be enrolled in aHT TwiC 1 and aHT 2 respectively. In case of complicated disease, unclear diagnosis, or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further investigation.

Eligibility criteria: Inclusion Criteria ComBaCaL-TwiC 1:

* Participant of the ComBaCaL cohort study (signed informed consent available)
* Living with aHT, defined as reporting intake of antihypertensive medication or being newly diagnosed during screening via standard diagnostic algorithm
* BP ≥140/90 mmHg at baseline

Inclusion criteria ComBaCaL-TwiC 2

* Participant of the ComBaCaL cohort study (signed informed consent available)
* Reporting intake of antihypertensive medication
* BP\<140/90 mmHg at baseline

Exclusion Criteria for both ComBaCaL-TwiC 1\&2:

* Reported pregnancy (at baseline or during follow-up)

Primary outcomes:
measure: Blood pressure (BP) within target (<140/90 mmHg)
timeFrame: 12 months after enrolment
Secondary outcomes:
measure: Change in 10-year risk for a fatal or non-fatal CVD event estimated using the World Health Organization (WHO) CVD risk prediction tool
timeFrame: 6 and 12 months after enrolment
measure: Change in dietary habits
timeFrame: 6 and 12 months after enrolment
measure: Change in International Physical Activity (PA) Questionnaire Short Form (IPAQ-SF)
timeFrame: 6 and 12 months after enrolment
measure: Change in total cholesterol
timeFrame: 6 and 12 months after enrolment
measure: Change in abdominal circumference
timeFrame: 6 and 12 months after enrolment
measure: Change in Body mass index (BMI)
timeFrame: 6 and 12 months after enrolment
measure: Blood pressure (BP) within target (<140/90 mmHg)
timeFrame: 6 months after enrolment
measure: Change in mean systolic blood pressure (SBP)
timeFrame: 6 and 12 months after enrolment
measure: Change in mean diastolic blood pressure (DBP)
timeFrame: 6 and 12 months after enrolment
measure: Change in occurrence of Serious Adverse Events (SAEs)
timeFrame: 6 and 12 months after enrolment
measure: Change in occurrence of Adverse Events of Special Interest (AESIs)
timeFrame: 6 and 12 months after enrolment
measure: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antihypertensive treatment
timeFrame: 6 and 12 months after enrolment
measure: Change in proportion of participants who are engaged in care
timeFrame: 6 and 12 months after enrolment
measure: Change in self-reported adherence to treatment
timeFrame: 6 and 12 months after enrolment
measure: Change in Quality of life (using EQ-5D-5L questionnaire)
timeFrame: 6 and 12 months after enrolment
Other outcomes:
Locations:
city: Maseru
country: Lesotho
facility: SolidarMed Lesotho
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Clinical Epidemiology
Study officials:
affiliation: University Hospital Basel, Division of Clinical Epidemiology
name: Niklaus Labhardt, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Basel, Division of Clinical Epidemiology
name: Alain Amstutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Sanchez-Samaniego G, Kohler M, Haldemann MI, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Sematle MP, Makabateng R, Mphunyane M, Phaaroe S, Basler DB, Kindler K, Burkard T, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based management of arterial hypertension and cardiovascular risk factors by lay village health workers for people with controlled and uncontrolled blood pressure in rural Lesotho: joint protocol for two cluster-randomized trials within the ComBaCaL cohort study (ComBaCaL aHT Twic 1 and ComBaCaL aHT TwiC 2). Trials. 2024 Jun 6;25(1):365. doi: 10.1186/s13063-024-08226-2.