Clinical trial NCT05094518: A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
Official title: A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prenatal Care
Pregnancy
Keywords: Mobile health
Refugee
Lead sponsor: HERA Inc
Sponsor class: OTHER
Collaborators: name: Medical Rescue Association (MEDAK), Turkey
First posted: 2021-10-26
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of attendance for prenatal care visits
timeFrame: 6 months
Secondary outcomes:
measure: Sociodemographic and Health information form data
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Founder/CEO
name: Aral Surmeli, MD
role: PRINCIPAL_INVESTIGATOR
References: