Interventions to Improve Non-communicable Disease Management During the Pandemic

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699369
• Other study ID #: PRCT202112
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2023
• Source: University of Toronto
• Contact: Muhammad Khan, PhD
• Phone: (92 51) 2611230-3
• Email: ccp[@]asd.com.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Noncommunicable Diseases

Intervention

Other:
• Digital health interventions
Described in arm descriptions.

Locations

Country	Name	City	State
Pakistan	Primary care facilities	Sargodha	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Association for Social Development, Pakistan, Canadian Institutes of Health Reesearch

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (mmHg) measured in the rural health center		At 10 months
Secondary	Diastolic blood pressure (mmHg) measured in the rural health center		At 10 months
Secondary	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
Secondary	Random blood glucose (mmol/L)		At 10 months
Secondary	Body mass index (BMI)		At 10 months
Secondary	Number of consultations with RHC doctors, including both in-person and virtual consultations		During the 10-month intervention period
Secondary	Systolic and diastolic blood pressure		At 6 months
Secondary	Proportion of patients who have had at least three doses of COVID vaccinations		At 10 months
Secondary	Proportion of participants been admitted to district hospitals for any reasons		During the 10-month intervention period
Secondary	All-cause mortality rate		During the 10-month intervention period