NCT05094518

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 7, 2021

Last Update Submit

October 21, 2021

Conditions

Keywords

Mobile healthRefugee

Outcome Measures

Primary Outcomes (1)

  • Rate of attendance for prenatal care visits

    The number of 4 mandatory prenatal care appointments that are attended are presented here.

    6 months

Secondary Outcomes (1)

  • Sociodemographic and Health information form data

    6 months

Study Arms (3)

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.

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.

Interventions

Appointment reminders in the form of push notifications will be sent through HERA app.

Reminder

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Aral Surmeli, MD

    Founder/CEO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

October 26, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share