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

NCT ID: NCT05662696

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-03-31

Brief 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.

Detailed 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.

Conditions

Preeclampsia; Pregnant With Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Raabta Telemonitoring Program (Mobile Application)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Seto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Central Contacts

Emily Seto, PhD

Role: CONTACT

emily.seto@utoronto.ca

416-669-9295

Anam Shahil Feroz, MSc

Role: CONTACT

anam.shahil@mail.utoronto.ca

6478676702

References

Shahil Feroz A, Yasmin H, Saleem S, Bhutta Z, Seto E. Feasibility of implementing a mobile phone-based telemonitoring programme to support pregnant women at high-risk for pre-eclampsia in Karachi, Pakistan: protocol for a mixed-methods study. BMJ Open. 2022 Dec 30;12(12):e070535. doi: 10.1136/bmjopen-2022-070535.

Reference Type: DERIVED

PMID: 36585144 (View on PubMed)

Other Identifiers

22-5220

Identifier Type: -

Identifier Source: org_study_id