COVID-19, Noncommunicable Diseases
Conditions
Keywords
digital health interventions, non-communicable diseases, cluster randomised trial, implementation science, resilience, Pakistan
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.
Interventions
Described in arm descriptions.
Sponsors
Association for Social Development, Pakistan
Canadian Institutes of Health Reesearch
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The research team will mask the statisticians when data is presented and analyzed.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure (mmHg) measured in the rural health center | At 10 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of consultations with RHC doctors, including both in-person and virtual consultations | During the 10-month intervention period |
| Systolic and diastolic blood pressure | At 6 months |
| All-cause mortality rate | During the 10-month intervention period |
| Proportion of patients who have had at least three doses of COVID vaccinations | At 10 months |
| Proportion of participants been admitted to district hospitals for any reasons | During the 10-month intervention period |
| Random blood glucose (mmol/L) | At 10 months |
| Body mass index (BMI) | At 10 months |
| 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 |
Countries
Pakistan
Contacts
Primary ContactMuhammad Khan, PhD
Outcome results
None listed