Interventions to Improve Non-communicable Disease Management During the Pandemic

NCT ID: NCT05699369

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2024-02-15

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.

Conditions

Noncommunicable Diseases; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital health interventions

Intervention Type: OTHER

Described in arm descriptions.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital health interventions

Described in arm descriptions.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association for Social Development, Pakistan

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Reesearch

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Xiaolin Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolin Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Primary care facilities

Sargodha, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad Khan, PhD

Role: CONTACT

ccp@asd.com.pk

(92 51) 2611230-3

Facility Contacts

Nida Khan

Role: primary

nidakhan@asd.com.pk

References

Wei X, Khan N, Durrani H, Muzaffar N, Haldane V, Walley JD, Thorpe K, Ge E, Ge S, Dodd W, Wallace J, Aslanyan G, Laporte A, Khan MA. Protocol for a pragmatic cluster randomised controlled trial to evaluate the effectiveness of digital health interventions in improving non-communicable disease management during the pandemic in rural Pakistan. PLoS One. 2023 Oct 10;18(10):e0282543. doi: 10.1371/journal.pone.0282543. eCollection 2023.

Reference Type: DERIVED

PMID: 37816010 (View on PubMed)

Other Identifiers

PRCT202112

Identifier Type: -

Identifier Source: org_study_id