Interventions to Improve Non-communicable Disease Management During the Pandemic

Sponsor

University of Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699369

Collaborator

Association for Social Development, Pakistan (Other), Canadian Institutes of Health Reesearch (Other)

1,500

Enrollment

Arms

12.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Noncommunicable Diseases COVID-19	Other: Digital health interventions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The research team will mask the statisticians when data is presented and analyzed.

Primary Purpose:

Health Services Research

Official Title:

A Cluster Randomised Controlled Trial to Evaluate the Effectiveness of Digital Health Interventions in Improving Non-communicable Disease Management During the Pandemic in Rural Pakistan

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Feb 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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.	Other: Digital health interventions Described in arm descriptions.
No Intervention: Control arm 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.

Arm

Intervention/Treatment

Experimental: Intervention arm

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.

Other: Digital health interventions

Described in arm descriptions.

No Intervention: Control arm

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.

Outcome Measures

Primary Outcome Measures

Systolic blood pressure (mmHg) measured in the rural health center [At 10 months]

Secondary Outcome Measures

Diastolic blood pressure (mmHg) measured in the rural health center [At 10 months]
Percentage of patients with controlled blood pressure measured below 140/90 mmHg for patients with hypertension but without diabetes, and below 130/80 mmHg for patients with diabetes [At 10 months]
Random blood glucose (mmol/L) [At 10 months]
Body mass index (BMI) [At 10 months]
Number of consultations with RHC doctors, including both in-person and virtual consultations [During the 10-month intervention period]
Systolic and diastolic blood pressure [At 6 months]
Proportion of patients who have had at least three doses of COVID vaccinations [At 10 months]
Proportion of participants been admitted to district hospitals for any reasons [During the 10-month intervention period]
All-cause mortality rate [During the 10-month intervention period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts 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.