Evaluating the Impact of a Symptom Checker on Healthcare-seeking Decisions: a Mixed-Methods Study (SAFEMOM)

January 28, 2025 updated by: Ada Health GmbH

Safety and Feasibility of the Integration of Ada Into the Mobile MomConnect Information Service for Pregnant Women and New Mothers in South Africa

The goal of this study is to evaluate the integration of a symptom checker (SC) into the MomConnect (MC) platform to support maternal healthcare in South Africa. The main questions it aims to answer are:

  • Does the SC provide safe and appropriate medical advice?
  • Does the SC help mothers make informed decisions about when and where to seek healthcare, saving time and money by avoiding unnecessary visits?
  • Does the SC improve access to care for those facing significant healthcare barriers?

Participants will answer survey questions before and after using the SC. A subset of participants will also be invited to participate in structured telephone interviews.

The study will help researchers assess the SC's impact on healthcare decisions and resource use in South Africa.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

968

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa
        • Reach Digital Health (formerly Praekelt.org)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of users of MomConnect a program developed by the National Department of Health (NDOH) in South Africa and Reach Digital Health for pregnant women and young mothers.

Description

Inclusion Criteria:

  • Women registered with MomConnect, who would like to assess their or their child's symptoms
  • At least 18 years of age
  • Women with access to WhatsApp
  • Capable of completing a symptom assessment in English

Exclusion Criteria:

  • Incapable of completing a symptom assessment in English via WhatsApp (e.g. due to illiteracy, language barrier, mental impairment or inebriation or other incapacity or lack of access to WhatsApp)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of appropriate advice by the SC for mother and child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
Proportion of safe advice by the SC for mother and child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Potential prevention of a health problem in Perinatal Period for Mother or Child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
Potential prevention of a SEVERE health problem in Perinatal Period for Mother or Child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
Potential Occurrence of a health problem (adverse event) in Perinatal Period for Mother and Child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
Potential Occurrence of a SEVERE health problem (severe adverse event) in Perinatal Period for Mother or Child
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.
Health seeking behaviour before and after using Ada+MomConnect
Time Frame: From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.
From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.
Number of participants who consulted an HCP after using Ada+MomConnect
Time Frame: After completion of the follow-up survey send out 1 week after enrolment.
After completion of the follow-up survey send out 1 week after enrolment.
Gaining of health information in a fast and standardised way
Time Frame: On the day of enrolment.
On the day of enrolment.
Usability
Time Frame: On the day of enrolment.
On the day of enrolment.
Time saved from avoiding unnecessary healthcare consultations
Time Frame: On the day of enrolment.
On the day of enrolment.
Time saved and associated estimate of income retained through avoiding unnecessary healthcare consultations
Time Frame: On the day of enrolment.
On the day of enrolment.
Healthcare resource utilisation
Time Frame: On the day of enrolment.
On the day of enrolment.
Direct Healthcare costs
Time Frame: On the day of enrolment.
On the day of enrolment.

Other Outcome Measures

Outcome Measure
Time Frame
Socioeconomic background of users
Time Frame: On the day of enrolment.
On the day of enrolment.
Subgroup analysis
Time Frame: From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment
From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment
Condition comparison
Time Frame: On the day of enrolment.
On the day of enrolment.
Time to receiving advice
Time Frame: On the day of enrolment.
On the day of enrolment.
Time to diagnosis
Time Frame: From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.
From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.
Quantitative and qualitative information collected in the phone survey on demographics, health seeking behaviour and user experience with the symptom checker
Time Frame: Approx. 1-2 weeks after enrolment.
Approx. 1-2 weeks after enrolment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ada Health GmbH

Collaborators

Rockefeller Foundation
Reach Digital Health (formerly Praekelt.org)
Citizen Surveys

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • StAP0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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