Clinical trial NCT05699369: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Noncommunicable Diseases
COVID-19
Keywords: digital health interventions
non-communicable diseases
cluster randomised trial
implementation science
resilience
Pakistan
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Association for Social Development, Pakistan
name: Canadian Institutes of Health Reesearch
First posted: 2023-01-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Systolic blood pressure (mmHg) measured in the rural health center
timeFrame: At 10 months
Secondary outcomes:
measure: Diastolic blood pressure (mmHg) measured in the rural health center
timeFrame: At 10 months
measure: 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
timeFrame: At 10 months
measure: Random blood glucose (mmol/L)
timeFrame: At 10 months
measure: Body mass index (BMI)
timeFrame: At 10 months
measure: Number of consultations with RHC doctors, including both in-person and virtual consultations
timeFrame: During the 10-month intervention period
measure: Systolic and diastolic blood pressure
timeFrame: At 6 months
measure: Proportion of patients who have had at least three doses of COVID vaccinations
timeFrame: At 10 months
measure: Proportion of participants been admitted to district hospitals for any reasons
timeFrame: During the 10-month intervention period
measure: All-cause mortality rate
timeFrame: During the 10-month intervention period
Other outcomes:
Locations:
city: Sargodha
country: Pakistan
facility: Primary care facilities
state: Punjab
Study officials:
affiliation: University of Toronto
name: Xiaolin Wei, PhD
role: PRINCIPAL_INVESTIGATOR
References: