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

Preeclampsia Clinical Trial

Official title:

Feasibility of Implementing a Mobile Phone-based Telemonitoring Program to Support Pregnant Women at High-risk for Preeclampsia in Karachi, Pakistan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05662696
• Other study ID #: 22-5220
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Emily Seto, PhD
• Phone: 416-669-9295
• Email: emily.seto[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Previous studies in LMICs have implemented telemonitoring by community health workers as part of the Community-Level Interventions for Preeclampsia (CLIP) trial and Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan, and Sri Lanka [COBRA-BPS] studies. These telemonitoring interventions relied on community health workers to record vital signs on a mobile application during in-person visits, which can miss signs of health issues during physical visits by the community health workers and can also introduce white coat hypertension or masked hypertension. The objective of this study is to enable early risk detection, diagnosis, and treatment of pregnant women at high-risk for preeclampsia between antenatal visits and to provide more frequent data than what can be achieved with home visits by community health workers. The study intervention will be the telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The telemonitoring program is named "Raabta" which means 'a connection' in Urdu. The Raabta technology has been developed at the Centre for Digital Therapeutics, University Health Network in Toronto, Canada. Hosting of the telemonitoring platform and storage of the patient data will be at the Centre for Digital Therapeutics, University Health Network. The patient-facing technology includes the Raabta smartphone application (app). The app will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor and to receive automated alerts (i.e., self-care messages) via the app. The app will use a rules-based algorithm which is developed using NICE guidelines and consultations from expert clinicians. The algorithm includes settings to trigger alerts and self-care messages for high-risk pregnant women with or without antihypertensives and symptoms of preeclampsia (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). Other features of the Raabta app include the use of local language (Urdu), illustrations for daily symptom monitoring questions (for pregnant women who cannot read), an easy-to-understand green-yellow-red alert system that uses the well-known traffic lights analogy, and voice message alerts in conjunction with the text. The clinician-facing technology includes the web-based Raabta dashboard. To support clinical decision-making, the medical officer situated at the JPMC OB-GYN outpatient department 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. The medical officer will act as a central point person to communicate with the patients (phone calls or using the asynchronous telemonitoring system chat feature) and with the rest of the participant's care team as needed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women at high-risk for preeclampsia (HRPE) who are either in their first or second trimester of pregnancy. The definition of HRPE will follow that of the NICE guidelines that define pregnant women at HRPE as those who have one high-risk factor or more than one moderate risk factor for preeclampsia.
• Participants who can speak and read (at least at a rudimentary level with help from a caregiver) the Urdu language for ease of communication with the research team and to be able to use the telemonitoring system.
• Partners (almost always male husbands in the Pakistani culture) and/or other caregivers (e.g., mother and mother-in-law) of pregnant women [for post-study interviews]
• Clinicians and nurses involved in the implementation of the telemonitoring program [for post-study interviews]

Exclusion Criteria:

• Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Pregnant With Complication

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Aga Khan University, Jinnah Postgraduate Medical Centre, University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Alerts	Total Number of Urgent Alerts (n), Total Number of Non-Urgent Alerts (n), Total Number of Normal Readings (n), Total Number of Red Alerts for Each Woman (n), Total Number of Yellow Alerts for Each Woman (n),	At study completion, approximately 1 year
Other	Mean systolic and diastolic blood pressure	Mean systolic blood pressure (mmhg), Mean diastolic blood pressure (mmhg)	At study completion, approximately 1 year
Primary	Acceptability	Rate of BP Task Compliance for Each Woman (BP readings aimed/sent by women), Rate of Symptom Task Compliance for Each Woman (Symptom readings aimed/sent by women), Compliance of all intended measurements for Each Woman (readings aimed/sent by women) (%), Month-wise Adherence of All Intended Measurements Rate for Each Women (%), Average Overall Adherence Rate of All Intended Measurements for Enrolled Women (%), and Month-wise Overall Adherence Rate of All Intended Measurements for Enrolled Women (%)	At study completion, approximately 1 year
Primary	Demand	Number of Women Consented to Participate in Raabta Program (n), Total Number of Women Enrolled in the Raabta Program (n), Number of Women Decided to Leave the Raabta Program (n), Number of Women Adhered to the Program Until Delivery (n), Length of time each patient enrolled with program/Duration of TM (Weeks), Number of Logins for Each Woman (n), and Total Number of Logins for All Enrolled Women (n)	At study completion, approximately 1 year
Primary	Practicality	Total Number of Calls Made by Medical Officer/Nurse to Each Woman (n), Total Number of Calls Made by Medical Officer/Nurse to All Enrolled Women (n), Total Number of Calls Made by Each Woman to Medical Officer/Nurse (n), Total Number of Calls Made by Enrolled Women (n), Total Number of Emails Received by Medical Officer/Nurse for Alerts (n), Total Number of Request for Changes in Raabta Program (n), and Total Number of Calls Received by Medical Officer/Nurse for Technical Support (n)	At study completion, approximately 1 year
Primary	Fidelity	Total Number of Request for Changes in Raabta Program (n)	At study completion, approximately 1 year
Secondary	Clinical efficacy	Presence of PE symptoms (Yes/No), Presence of Gestational Hypertension (Yes/No), Presence of Preeclampsia at Delivery (Yes/No), Presence of Eclampsia at Delivery (Yes/No), Presence of HELLP Syndrome (Yes/No), and Presence of Suspected Fetal Growth Restriction (Yes/No)	At study completion, approximately 1 year