Clinical trial NCT05662696: Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan
Official title: Feasibility of Implementing a Mobile Phone-based Telemonitoring Program to Support Pregnant Women at High-risk for Preeclampsia in Karachi, Pakistan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preeclampsia
Pregnant With Complication
Keywords: Telemonitoring
mHealth
Remote monitoring
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Jinnah Postgraduate Medical Centre
name: Aga Khan University
name: University of Toronto
First posted: 2022-12-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Acceptability
timeFrame: At study completion, approximately 1 year
measure: Demand
timeFrame: At study completion, approximately 1 year
measure: Practicality
timeFrame: At study completion, approximately 1 year
measure: Fidelity
timeFrame: At study completion, approximately 1 year
Secondary outcomes:
measure: Clinical efficacy
timeFrame: At study completion, approximately 1 year
Other outcomes:
measure: Number of Alerts
timeFrame: At study completion, approximately 1 year
measure: Mean systolic and diastolic blood pressure
timeFrame: At study completion, approximately 1 year
Locations:
Study officials:
affiliation: University of Toronto
name: Emily Seto, PhD
role: PRINCIPAL_INVESTIGATOR
References: