Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania

Hypertension Clinical Trial

Official title:

STOP NCDs: Scaling up Evidence-based Health System Interventions Through the Use of Sustainable Healthcare Financing and Digital technOlogy Platforms to Improve Non- Communicable Disease Prevention and Control in Tanzania

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379750
• Other study ID #: STOPNCD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1320
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.

Exclusion Criteria:

• Adults with controlled HTN or those without a diagnosis of HTN

• Unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Other:
• Nurse-delivered care using WelTel check-ins and BCC SMS
Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS
• Community-based peer-support model
Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Change in systolic blood pressure from baseline to last follow-up visit	12 months
Secondary	Blood pressure control	Proportion of participants with controlled blood pressure (<140 mm Hg for systolic and <90 mm Hg for diastolic) at the last follow-up visit	12 months