Effect of a Mobile Health Intervention on Birth Outcomes

Официальное название

Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal

Обзор

Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviours for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery. Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up). Follow-up will be done from the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.

Подробное описание

To evaluate the effect of mobile health intervention on birth outcomes, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher will employ purposive sampling to select pregnant women visiting antenatal care clinic of selected hospital. Written informed consent will be obtained from research participants. Focus group discussions will be conducted with pregnant women to explore their views, informational needs and preferences regarding utilization of mHealth intervention. An educational video will be developed based on the findings of the qualitative study. After the video is developed, it will be validated by both expert and user groups to ensure its relevance, accuracy, and suitability. Additionally, the acceptability of the intervention will be assessed. The researcher will ensure that the educational video is user-centred by involving both experts and end users (pregnant women) throughout the design and development process.

After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD.

Phase 1: Recruitment, baseline data collection and randomization:

The head of the obstetrics and paediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinics, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 13 to 27 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at selected hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "pregnancy care for a healthy birth" from the participants in both the intervention and control groups.

Phase 2: Delivery of the intervention:

Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed.

Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events:

* During the baseline data collection phase, the initial educational video addressing "pregnancy care for a healthy birth" will be viewed by participants via a tablet in a separate designated setting. * Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy. * Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic. * To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrolment as per the reminder schedule. * Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others.

Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit.

Phase 3: Follow up

Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits.

• Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of pregnancy care for healthy birth will be assessed approximately one month following the participants' initial viewing of the videos.

• Birth outcomes assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes.

Вмешательства

• Поведенческое mHealth intervention (educational video, SMS and reminder phone call)
  Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive mHealth intervention that includes a tailored educational video, SMS messages, and reminder phone calls for follow-up

Первичные конечные точки

• Birth weight [Срок оценки: 2-2.5 years]
• Gestational age at delivery [Срок оценки: 2-2.5 years]

Вторичные конечные точки (1)

• Knowledge on pregnancy care [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Pregnant women of age 18 years and above;
• Pregnant with 13 to 27 weeks of gestation;
• Planned to deliver a child at selected hospital;
• Pregnant women who use smart phone;
• Can read and understand Nepali language

Критерии исключения

• Pregnant women with vision impairment and diagnosed learning difficulties

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Nepal · 1 центр

• Bhawana Shrestha — Dhulikhel

Публикации

• Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug. PMID 26425706
• Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8. PMID 36151526
• Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21. PMID 25178042
• Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early chi PMID 32005294
• Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019. PMID 35252905
• Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019. PMID 33134854

Идентификаторы

NCT: NCT06431581 · NHRC 42-2042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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