A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aral Surmeli, MD
- 電話番号：+905353140179
- メール：a.surmeli@medak.org.tr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of attendance for prenatal care visits
時間枠：6 months
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The number of 4 mandatory prenatal care appointments that are attended are presented here.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sociodemographic and Health information form data
時間枠：6 months
|
Data about sociodemographic and health information of participants will be presented here.
|
6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Aral Surmeli, MD、Founder/CEO
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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