- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05094518
A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aral Surmeli, MD
- 전화번호: +905353140179
- 이메일: a.surmeli@medak.org.tr
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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Appointment reminders in the form of push notifications will be sent through HERA app.
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간섭 없음: 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.
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|
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of attendance for prenatal care visits
기간: 6 months
|
The number of 4 mandatory prenatal care appointments that are attended are presented here.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sociodemographic and Health information form data
기간: 6 months
|
Data about sociodemographic and health information of participants will be presented here.
|
6 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Aral Surmeli, MD, Founder/CEO
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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