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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Agency for Development and Cooperation (SDC); World Diabetes Foundation (WDF)
• Treatments: Antihypertensive Agents

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:

• Severe comorbidity with a presumed life-expectancy of less than twelve months

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