Interventions to Improve Non-communicable Disease Management During the Pandemic

NCT05699369 | Unknown

• 1 other identifier: PRCT202112
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Keywords

digital health interventions; non-communicable diseases; cluster randomised trial; implementation science; resilience; Pakistan

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure (mmHg) measured in the rural health center

  At 10 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Digital health interventions OTHER

Described in arm descriptions.

Intervention arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• Association for Social Development, Pakistan: collaborator
• Canadian Institutes of Health Reesearch: collaborator

Study Sites (1)

Primary care facilities

Sargodha, Punjab Province, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37816010 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaolin Wei, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Khan, PhD

CONTACT

(92 51) 2611230-3; ccp@asd.com.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team will mask the statisticians when data is presented and analyzed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 25, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication in peer-reviewed journals.
• Access Criteria: The research team will aim to publish them in open access journals as priority so that all other researchers will freely access to them.

Locations

PA (1)