Interventions to Improve Non-communicable Disease Management During the Pandemic

University of Toronto

Status: Enrolling

Conditions: COVID-19; Noncommunicable Diseases

Treatments: Other: Digital health interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT05699369

PRCT202112

Details and patient eligibility

About

This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. The main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective.

30 rural health centers in Punjab Province, Pakistan will be randomized into two groups. The intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of NCDs during the pandemic, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Usual care will be provided in the control group. Researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 10 months.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reside in the catchment of selected rural health centers;
• Provide informed consent;
• Newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmHg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmHg;
• Have a smartphone or can access a smartphone from a relative.

Exclusion criteria

• Patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Intervention arm

Experimental group

Description:

A comprehensive package of digital health interventions to connect patients, patient champions and public health providers to improve the management of non-communicable diseases (NCDs) during the pandemic will be implemented, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Patient champions are experienced patients who can provide peer support.

Treatment:

Other: Digital health interventions

Control arm

No Intervention group

Description:

Usual care, which is routine hypertension and diabetes diagnosis and treatment under the World Diabetes Foundation (WDF) project will be implemented. The WDF project provides initial Zoom-based training of NCD care to rural health center (RHC) staff, but no tele-mentorship is offered. Under the usual care, patients with hypertension or diabetes are required to visit RHCs every month to renew their medications and measure their blood pressure. No other interventional components will be implemented in the control arm.