Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan

Sponsor
University Health Network, Toronto
Study ID
NCT05662696
Status
Recruiting
Apply to this trial

Conditions

  • Preeclampsia
  • Pregnant With Complication

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Raabta Telemonitoring Program (Mobile Application) — OTHER
    Raabta is a smartphone application that will allow pregnant women at high-risk for preeclampsia to measure and record daily blood pressure readings and self-reported symptoms. An algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated alert self-care message based on their measurements and reported symptoms.

Study Details

High maternal mortality from preeclampsia/eclampsia results from a lack of early identification and management of pregnant women at high risk for preeclampsia. A potential tool to support pregnant women at high risk for preeclampsia is telemonitoring. Most telemonitoring interventions have been implemented in high-income countries and thus there is limited evidence on the use and effectiveness of telemonitoring for pregnant women in low-middle-income countries (LMICs). The scarce evidence on the feasibility of telemonitoring program implementation limits the understanding of the process and mechanisms through which the intervention works in LMICs. The study will explore the feasibility of implementing a mobile phone-based telemonitoring program for pregnant women at high-risk for preeclampsia in Karachi, Pakistan. The study will be conducted at the Jinnah Post Graduate Medical Center in Karachi, Pakistan. The study will use a mixed-methods design to recruit 50 pregnant women at high risk for preeclampsia to assess clinical feasibility across the five foci of Bowen's framework including acceptability, demand, implementation, practicality, and limited-efficacy testing. Data sources will include semi-structured interviews with the patients, and clinicians, as well as data from paper medical records, research logs, and server data. The results of the quantitative and qualitative data will be analyzed separately and then integrated at the interpretation and reporting levels to advance our understanding of the telemonitoring program's feasibility. This will be the first study to provide evidence on the feasibility of using a telemonitoring program where pregnant women at high-risk for preeclampsia in Pakistan will take their own blood pressure readings at home.

Key Dates

First listed
Dec 22, 2022
Start date
Aug 4, 2024
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan
    The study intervention includes a telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The trial will administer the telemonitoring program to 50 pregnant women at high risk for preeclampsia. The intervention will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor, to report if participants have symptoms, and to receive automated alerts and self-care messages (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). A healthcare provider (medical officer) will receive alerts from the telemonitoring system if the patient's blood pressure trends are out of the target or if the patient is reporting symptoms.

Primary Outcome Measure

Acceptability [ Time Frame: At study completion, approximately 1 year ]

Central Contacts

Related Studies