Maternal Health CareSAFEMOMNCT06790069

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

An observational study of Maternal Health Care, run by Ada Health GmbH at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Maternal Health Care
How many people: 968 participants
Where: 1 siteSouth Africa
Study dates: 4 May 2023to 15 Aug 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Reach Digital Health (formerly Praekelt.org)
Cape Town

Other trials in South Africa

About this study

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

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.

Conditions: Maternal Health Care
Keywords: maternal health, mobile health tools, symptom checker

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

Potential prevention of a health problem in Perinatal Period for Mother or Child
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After completion of the follow-up survey send out 1 week after enrolment.
Gaining of health information in a fast and standardised way
Measured: On the day of enrolment.
Usability
Measured: On the day of enrolment.
Time saved from avoiding unnecessary healthcare consultations
Measured: On the day of enrolment.
Time saved and associated estimate of income retained through avoiding unnecessary healthcare consultations
Measured: On the day of enrolment.
Healthcare resource utilisation
Measured: On the day of enrolment.
Direct Healthcare costs
Measured: On the day of enrolment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202315 Aug 2023

First posted23 Jan 2025
Study start4 May 2023
Primary completion15 Aug 2023
Study completion15 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Maternal Health CareStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 968 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06790069
Sponsor's protocol ID: StAP0012
Acronym: SAFEMOM
Status last verified: Jan 2025
First submitted: 16 Jan 2025
Last updated: 30 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced

All Maternal Health Care trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Feasibility of the Integration of Ada Into the Mobile MomConnect Information Service for Pregnant Women and New Mothers in South Africa
ClinicalTrials.gov ID: NCT06790069
Acronym / sponsor ID: SAFEMOM / StAP0012
Conditions: Maternal Health Care
Keywords: maternal health, mobile health tools, symptom checker
Study type: Observational
Recruitment status: Completed
Enrolment: 968 participants (actual)
Lead sponsor: Ada Health GmbHIndustry (pharma, biotech, devices)
Collaborators: Reach Digital Health (formerly Praekelt.org), Citizen Surveys, Rockefeller Foundation
Study start: 4 May 2023 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 23 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Other
Time perspective: Other

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

12 secondary outcomes

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.
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.
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.
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.
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.
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.
Gaining of health information in a fast and standardised way
Time frame: On the day of enrolment.
Usability
Time frame: On the day of enrolment.
Time saved from avoiding unnecessary healthcare consultations
Time frame: 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.
Healthcare resource utilisation
Time frame: On the day of enrolment.
Direct Healthcare costs
Time frame: On the day of enrolment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Maternal Health Care

Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Maternal Health Care, run by Ada Health GmbH at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.