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

NCT05662696 | Not Yet Recruiting

• 1 other identifier: 22-5220
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preeclampsia; Pregnant With Complication

Keywords

Telemonitoring; mHealth; Remote monitoring

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Fidelity

  Total Number of Request for Changes in Raabta Program (n)

  At study completion, approximately 1 year

Secondary Outcomes (1)

• Clinical efficacy

  At study completion, approximately 1 year

Other Outcomes (2)

• Number of Alerts

  At study completion, approximately 1 year

• Mean systolic and diastolic blood pressure

  At study completion, approximately 1 year

Study Arms (1)

Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan

EXPERIMENTAL

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.

Other: Raabta Telemonitoring Program (Mobile Application)

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.

Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[for post-study interviews\]

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Jinnah Postgraduate Medical Centre: collaborator
• Aga Khan University: collaborator
• University of Toronto: collaborator

Related Publications (1)

• 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.

  PMID: 36585144 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Emily Seto, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Seto, PhD

CONTACT

416-669-9295; emily.seto@utoronto.ca

Anam Shahil Feroz, MSc

CONTACT

6478676702; anam.shahil@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: December 22, 2022
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05