Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan
NCT05662696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-05-28
Summary
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.
Conditions
- Preeclampsia
- Pregnant With Complication
Interventions
- OTHER
-
Raabta Telemonitoring Program (Mobile Application)
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.
Sponsors & Collaborators
-
Jinnah Postgraduate Medical Centre
collaborator OTHER_GOV -
Aga Khan University
collaborator OTHER -
University of Toronto
collaborator OTHER -
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Emily Seto, PhD · University of Toronto
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-03-31
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