Prenatal CareNCT05094518
A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
A study testing Mobile phone reminders in people with Prenatal Care and Pregnancy, run by HERA Inc.
Trial summary
The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Care, Pregnancy
- What is being tested?
- Mobile phone reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having the status of "Syrian under temporary protection"
- Being in the first trimester of the pregnancy
- Initial prenatal visit
- Age equal or greater than 18 years and less than or equal to 49
Who cannot join
- Having a citizenship or a status other than "Syrian under temporary protection"
- Not owning a mobile phone
- Being unable to read and write
- Not initial prenatal visit
- Having a chronic disorder or high-risk pregnancy that requires the individual to go to the hospital frequently. Frequently is defined as more than 3 visits post the baseline visit.
- While gestating, those that develop a high-risk pregnancy that requires more than 3 visits post the baseline visit.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population.
Read the detailed description
Background: 12 million Syrians have been forcibly displaced from their homes since the start of Syrian Civil War in 2011. Despite Turkey providing free healthcare services through national insurance to nearly 4 million refugees that it hosts, pregnant Syrian women are less likely to attend prenatal visits and more likely to die during and after labor. An increase in the uptake of prenatal care may improve quality of life through healthy pregnancies and safer labor conditions in this population with double vulnerability.
Mobile phone-based reminders have been shown in randomized controlled trials and systematic reviews to increase the uptake of various services, including prenatal care. Mobile phone penetration is high among Syrian refugees in Turkey and qualitative studies demonstrate that mobile health interventions are acceptable and feasible for Syrian refugees.
Primary objective: To evaluate the impact of mobile phone-based reminders on the uptake of prenatal care among pregnant Syrian refugee women. More specifically, the study assesses the effectiveness of mobile phone-based reminders by measuring the percent increase in the number of prenatal appointments attended by intervention arm participants compared to the control arm participants.
Study design: This is a behavioral intervention study using an un-blinded, parallel groups, randomized controlled study design.
Primary Outcome:
The primary outcome of this study is the number of medical visits, following the initial baseline prenatal care visit, over the 6 month period prior to childbirth.
Secondary outcomes:
Secondary outcomes are based on the Sociodemographic and Health History form. The form gathers information about demographics of the participants (age, education, employment, marital status, number of children) and health history (previous pregnancies, delivery methods, miscarriages, stillborn, chronic conditions and medications. We will further examine these risk factors on the number of medical visits during the study period.
- Conditions
- Prenatal Care, Pregnancy
- Being tested
- Mobile phone reminders
- Keywords
- Mobile health, Refugee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone remindersBehavioural
Appointment reminders in the form of push notifications will be sent through HERA app.
| Study group | Role | What they receive |
|---|---|---|
| Reminder | Experimental | Participants will fill the sociodemographic and health history form. Participants will receive reminders in the form of push notifications for prenatal checkup dates automatically generated according to their pregnancy start data or initial check-up appointment for 6 months. Reminders will be sent at the following intervals: 1) 2 weeks before the appointment, 2) 1 day before the appointment, and 3) on the day of appointment. After this date, participants will receive push notifications asking whether they went to the appointment or not weekly for 1 month. This reminder algorithm will be used for each prenatal checkup for a total of four appointments: once in first trimester, once in second trimester and two in third trimester, using the World Health Organization and Turkish Ministry of Health prenatal checkup calendar. At the end of 6 months of follow up period, participants will be contacted via phone call to ask for any remaining appointments or unanswered notifications. Receives: Behavioral: Mobile phone reminders |
| Informed Control No Reminder | No intervention | Participants will fill the sociodemographic and health history form. Their contact information will be gathered. Participants will be contacted at the end of 6 months and will be asked about the number of the prenatal care appointments they have attended during their pregnancy. |
| Uninformed Control No Reminder | No intervention | Participants will fill the sociodemographic and health history form. No contact information will be gathered. The purpose of this arm is to estimate the "true" baseline for the number of visits without any extra attention given by the medical staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of attendance for prenatal care visits
The number of 4 mandatory prenatal care appointments that are attended are presented here.
Measured: 6 months
Secondary outcomes (1)
Sociodemographic and Health information form data
Data about sociodemographic and health information of participants will be presented here.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group cluster will use the HERA application to receive appointment reminders. The Informed and Non-Informed Control groups will not be using the HERA application.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HERA Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Rescue Association (MEDAK), Turkey
- Responsible party
- Sponsor
- Investigators
- Aral Surmeli, MD, Principal investigator, Founder/CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094518
- Sponsor's protocol ID
- HeraInc
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
- ClinicalTrials.gov ID
- NCT05094518
- Acronym / sponsor ID
- HeraInc
- Conditions
- Prenatal Care, Pregnancy
- Keywords
- Mobile health, Refugee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- HERA IncUniversity, hospital or other
- Collaborators
- Medical Rescue Association (MEDAK), Turkey
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Oct 2021 (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.
The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population.
Detailed description
Background: 12 million Syrians have been forcibly displaced from their homes since the start of Syrian Civil War in 2011. Despite Turkey providing free healthcare services through national insurance to nearly 4 million refugees that it hosts, pregnant Syrian women are less likely to attend prenatal visits and more likely to die during and after labor. An increase in the uptake of prenatal care may improve quality of life through healthy pregnancies and safer labor conditions in this population with double vulnerability.
Mobile phone-based reminders have been shown in randomized controlled trials and systematic reviews to increase the uptake of various services, including prenatal care. Mobile phone penetration is high among Syrian refugees in Turkey and qualitative studies demonstrate that mobile health interventions are acceptable and feasible for Syrian refugees.
Primary objective: To evaluate the impact of mobile phone-based reminders on the uptake of prenatal care among pregnant Syrian refugee women. More specifically, the study assesses the effectiveness of mobile phone-based reminders by measuring the percent increase in the number of prenatal appointments attended by intervention arm participants compared to the control arm participants.
Study design: This is a behavioral intervention study using an un-blinded, parallel groups, randomized controlled study design.
Primary Outcome:
The primary outcome of this study is the number of medical visits, following the initial baseline prenatal care visit, over the 6 month period prior to childbirth.
Secondary outcomes:
Secondary outcomes are based on the Sociodemographic and Health History form. The form gathers information about demographics of the participants (age, education, employment, marital status, number of children) and health history (previous pregnancies, delivery methods, miscarriages, stillborn, chronic conditions and medications. We will further examine these risk factors on the number of medical visits during the study period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention group cluster will use the HERA application to receive appointment reminders. The Informed and Non-Informed Control groups will not be using the HERA application.
| Arm | Type | Receives |
|---|---|---|
| Reminder | Experimental | Behavioral: Mobile phone remindersParticipants will fill the sociodemographic and health history form. Participants will receive reminders in the form of push notifications for prenatal checkup dates automatically generated according to their pregnancy start data or initial check-up appointment for 6 months. Reminders will be sent at the following intervals: 1) 2 weeks before the appointment, 2) 1 day before the appointment, and 3) on the day of appointment. After this date, participants will receive push notifications asking whether they went to the appointment or not weekly for 1 month. This reminder algorithm will be used for each prenatal checkup for a total of four appointments: once in first trimester, once in second trimester and two in third trimester, using the World Health Organization and Turkish Ministry of Health prenatal checkup calendar. At the end of 6 months of follow up period, participants will be contacted via phone call to ask for any remaining appointments or unanswered notifications. |
| Informed Control No Reminder | No intervention | –Participants will fill the sociodemographic and health history form. Their contact information will be gathered. Participants will be contacted at the end of 6 months and will be asked about the number of the prenatal care appointments they have attended during their pregnancy. |
| Uninformed Control No Reminder | No intervention | –Participants will fill the sociodemographic and health history form. No contact information will be gathered. The purpose of this arm is to estimate the "true" baseline for the number of visits without any extra attention given by the medical staff. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having the status of "Syrian under temporary protection"
- Being in the first trimester of the pregnancy
- Initial prenatal visit
- Age equal or greater than 18 years and less than or equal to 49
Key exclusion criteria (6 listed)
- Having a citizenship or a status other than "Syrian under temporary protection"
- Not owning a mobile phone
- Being unable to read and write
- Not initial prenatal visit
- Having a chronic disorder or high-risk pregnancy that requires the individual to go to the hospital frequently. Frequently is defined as more than 3 visits post the baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone remindersAppointment reminders in the form of push notifications will be sent through HERA app. | Behavioural | Reminder |
Primary outcome
Rate of attendance for prenatal care visits
Time frame: 6 months
The number of 4 mandatory prenatal care appointments that are attended are presented here.
1 secondary outcome
Sociodemographic and Health information form data
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Aral Surmeli, MD principal investigator
Founder/CEO
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone reminders in people with Prenatal Care and Pregnancy, run by HERA Inc.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aral Surmeli, MD (+905353140179, a.surmeli@medak.org.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of attendance for prenatal care visits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2021.