"Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)

NCT05684055 | Active Not Recruiting

• 1 other identifier: AO_2022-00074; am22Labhardt2
• Study Type: interventional
• Target: 1,354
• Locations: 2 countries
• Sites: 2

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.

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)

Outcome Measures

Primary Outcomes (1)

• Blood pressure (BP) within target (<140/90 mmHg)

  Proportion of participants whose blood pressure (BP) is within target (\<140/90 mmHg)

  12 months after enrolment

Secondary Outcomes (15)

• Change in 10-year risk for a fatal or non-fatal CVD event estimated using the World Health Organization (WHO) CVD risk prediction tool

  6 and 12 months after enrolment

• Change in dietary habits

  6 and 12 months after enrolment

• Change in International Physical Activity (PA) Questionnaire Short Form (IPAQ-SF)

  6 and 12 months after enrolment

• Change in total cholesterol

  6 and 12 months after enrolment

• Change in abdominal circumference

  6 and 12 months after enrolment

Study Arms (2)

Intervention villages

ACTIVE COMPARATOR

CC-VHWs do screen, diagnosis, first-line aHT treatment for eligible participants, treatment monitoring at community-level (ComBaCaL app guides them to provide first-line antihypertensive SPCs to eligible individuals and treatment monitoring/ support to all individuals with aHT). CC- VHW offers lifestyle counselling, lipid -lowering treatment to participants with high CVD risk and antiplatelet treatment to participants with history of stroke/ myocardial infarction. Trained, supervised, mentored by chronic care nurses (CC nurses) and guided by the ComBaCaL app they follow-up persons with aHT to monitor adherence, life-style changes, treatment response, side-effects. TwiC 1: individuals with uncomplicated aHT (baseline BP above treatment targets) TwiC 2: individuals with uncomplicated pharmacologically controlled aHT. In case of complicated disease or presence of clinical alarm signs/ symptoms, participants are referred to the closest health facility for further investigation.

Drug: First-line antihypertensive single-pill combination (SPC)

Control villages

ACTIVE COMPARATOR

Control villages will follow the standard of care in the ComBaCaL cohort study. CC-VHWs will also receive tablets with the ComBaCaL app installed. They are trained, supervised and equipped to screen and diagnose aHT with subsequent referral to facility-based follow-up and care. In control villages the ComBaCaL app supports clinical decision making and documentation for screening, diagnosis and referral, but not prescription/ provision of antihypertensive or lipid-lowering medication. TwiC 1: enrols individuals with uncomplicated aHT with baseline BP values above treatment targets. TwiC 2: enrols individuals with uncomplicated pharmacologically controlled aHT. In case of complicated hypertension or presence of clinical alarm signs or symptoms, participants will be immediately referred to the closest health facility for further investigation.

Other: Standardized counselling and referral to the closest health facility

Interventions

First-line antihypertensive single-pill combination (SPC) DRUG

In intervention villages, participants diagnosed with aHT are offered pharmacological treatment (eHealth supported prescription of first-line antihypertensive single-pill combination (SPC)) and treatment monitoring in the villages by CC-VHWs guided by the ComBaCaL app.

Intervention villages

Standardized counselling and referral to the closest health facility OTHER

In control villages, participants diagnosed with aHT receive a standardized counselling by the CC-VHW and are referred to the closest health facility for initiation or continuation of antihypertensive treatment.

Control villages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

SolidarMed Lesotho

Maseru, Lesotho

Location

University Hospital Basel, Division of Clinical Epidemiology

Basel, 4051, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 38845045 BACKGROUND

• Gerber F, Sanchez-Samaniego G, Gupta R, Lejone TI, Tahirsylaj T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Mofokeng M, Sematle MP, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Burkard T, Chammartin F, Amstutz A, Labhardt ND. Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial. Nat Med. 2026 Feb 12. doi: 10.1038/s41591-026-04208-w. Online ahead of print.

  PMID: 41680483 DERIVED

MeSH Terms

Conditions

Hypertension; Noncommunicable Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niklaus Labhardt, Prof.

  University Hospital Basel, Division of Clinical Epidemiology

  PRINCIPAL INVESTIGATOR

• Alain Amstutz, MD

  University Hospital Basel, Division of Clinical Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 13, 2023
• Study Start: September 9, 2023
• Primary Completion: May 4, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 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)