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Interventions to Improve Non-communicable Disease Management During the Pandemic

Primary Purpose

Noncommunicable Diseases, COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Digital health interventions
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Noncommunicable Diseases focused on measuring digital health interventions, non-communicable diseases, cluster randomised trial, implementation science, resilience, Pakistan

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Primary care facilitiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diastolic blood pressure (mmHg) measured in the rural health center
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
Random blood glucose (mmol/L)
Body mass index (BMI)
Number of consultations with RHC doctors, including both in-person and virtual consultations
Systolic and diastolic blood pressure
Proportion of patients who have had at least three doses of COVID vaccinations
Proportion of participants been admitted to district hospitals for any reasons
All-cause mortality rate

Full Information

First Posted
January 16, 2023
Last Updated
May 9, 2023
Sponsor
University of Toronto
Collaborators
Association for Social Development, Pakistan, Canadian Institutes of Health Reesearch
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1. Study Identification

Unique Protocol Identification Number
NCT05699369
Brief Title
Interventions to Improve Non-communicable Disease Management During the Pandemic
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Association for Social Development, Pakistan, Canadian Institutes of Health Reesearch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noncommunicable Diseases, COVID-19
Keywords
digital health interventions, non-communicable diseases, cluster randomised trial, implementation science, resilience, Pakistan

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The research team will mask the statisticians when data is presented and analyzed.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm 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.
Arm Title
Control arm
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Digital health interventions
Intervention Description
Described in arm descriptions.
Primary Outcome Measure Information:
Title
Systolic blood pressure (mmHg) measured in the rural health center
Time Frame
At 10 months
Secondary Outcome Measure Information:
Title
Diastolic blood pressure (mmHg) measured in the rural health center
Time Frame
At 10 months
Title
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
Time Frame
At 10 months
Title
Random blood glucose (mmol/L)
Time Frame
At 10 months
Title
Body mass index (BMI)
Time Frame
At 10 months
Title
Number of consultations with RHC doctors, including both in-person and virtual consultations
Time Frame
During the 10-month intervention period
Title
Systolic and diastolic blood pressure
Time Frame
At 6 months
Title
Proportion of patients who have had at least three doses of COVID vaccinations
Time Frame
At 10 months
Title
Proportion of participants been admitted to district hospitals for any reasons
Time Frame
During the 10-month intervention period
Title
All-cause mortality rate
Time Frame
During the 10-month intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Khan, PhD
Phone
(92 51) 2611230-3
Email
ccp@asd.com.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin Wei, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary care facilities
City
Sargodha
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nida Khan
Email
nidakhan@asd.com.pk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.
IPD Sharing Time Frame
After publication in peer-reviewed journals.
IPD Sharing 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.

Learn more about this trial

Interventions to Improve Non-communicable Disease Management During the Pandemic

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