- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05094518
A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Aral Surmeli, MD
- Telefonnummer: +905353140179
- E-post: a.surmeli@medak.org.tr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Reminder
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.
|
Appointment reminders in the form of push notifications will be sent through HERA app.
|
Inget ingripande: Informed Control No Reminder
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.
|
|
Inget ingripande: Uninformed Control No Reminder
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rate of attendance for prenatal care visits
Tidsram: 6 months
|
The number of 4 mandatory prenatal care appointments that are attended are presented here.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sociodemographic and Health information form data
Tidsram: 6 months
|
Data about sociodemographic and health information of participants will be presented here.
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Aral Surmeli, MD, Founder/CEO
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HeraInc
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Graviditet
-
King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekryteringCirros, lever | HELLP syndrom | Intrahepatisk kolestas av graviditet | Graviditetssjukdom | AFLP - Acute Fatty Lever of PregnancyStorbritannien
Kliniska prövningar på Mobile phone reminders
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)Avslutad
-
The Hong Kong Polytechnic UniversityRekryteringStroke | Bärbar enhetHong Kong
-
The Hong Kong Polytechnic UniversityAvslutad
-
University of MinnesotaBrown University; University of Michigan; Advanced Medical ElectronicsAvslutad
-
Regenstrief Institute, Inc.Merck Sharp & Dohme LLC; Indiana UniversityAvslutadLivmoderhalscancer | Orofaryngeal cancer | Könsvårtor | Humant papillomvirusinfektion typ 11 | Humant papillomvirusinfektion typ 16 | Humant papillomvirusinfektion typ 18 | Humant papillomvirusinfektion typ 6
-
United States Department of DefenseAktiv, inte rekryterande
-
VA Office of Research and DevelopmentHar inte rekryterat ännuAmyotrofisk lateral skleros | Muskeldystrofi | Ryggmärgsskada | Infarkter i hjärnstammen | Inlåst syndromFörenta staterna
-
Sun Yat-sen UniversityRekrytering
-
Seoul National University Childrens HospitalHanyang University; Wonkwang University HospitalOkändAttention Deficit Hyperactivity DisorderKorea, Republiken av
-
Sofia Segura-PérezYale University; Cornell UniversityAvslutad