Randomized controlled trial on effectiveness of mHealth (mobile/smartphone) based Preterm Home Care Program on developmental outcomes of preterms: Study protocol

• Published in: Journal of advanced nursing 2019-02, Vol.75 (2), p.452-460
• Main Authors: Nayak, Baby S., Lewis, Leslie Edward, Margaret, Binu, Bhat Y, Ramesh, D'Almeida, Joslin, Phagdol, Tenzin
• Format: Article
• Language: English
• Subjects: Activism; Biotechnology; Child care; Child development; Clinical outcomes; Clinical research; Clinical trials; community health worker; Community health workers; development; Evidence-based nursing; growth; Health services; Health status; Home based; Home health care; India; Infants; Intensive care; Intervention; Maternal and infant welfare; Medical personnel; Medical technology; mHealth; mobile health application; Mother-infant relations; mother–infant interaction; Newborn babies; Nursing; Parent-child relations; Parents & parenting; Premature babies; Premature birth; premature infants; preterm home care; Smartphones; Software; Telemedicine; Will; Working mothers
• ISSN: 0309-2402; 1365-2648
• DOI: 10.1111/jan.13879

Aim To describe a randomized controlled trial protocol designed to evaluate the effectiveness of mobile health based Preterm Home Care Program (mHealthPHCP) known as “NeoRaksha” mobile health application in improving parent‐infant‐interaction, growth and development of preterms. Design A prospective, randomized controlled clinical trial. The protocol is approved and funded by Department of Biotechnology, Government of India on 2 August 2016. Methods A total of 300 preterm‐mother dyads admitted to neonatal intensive care unit of a tertiary care hospital will be recruited and randomized to intervention and control group. The intervention group would receive mobile health based Preterm Home Care Program and the control group would receive standard preterm care. Intervention group will be followed up at home by community health workers known as Accredited Social Health Activist who will be trained in using the NeoRaksha mobile health application. Preterms outcomes will be assessed during follow‐up at hospital. Discussion Supporting continuity of preterm care is vital as parents and preterms experience transition from Neonatal Intensive Care unit to their home. Empowering mothers and community health workers by integrating mobile technology into health care can help promote healthy preterms, enhance development outcomes and follow‐up, which in turn can reduce the mortalities, morbidities, and disabilities associated with prematurity. Impact The results of this study could open up new horizons in integrating hospital and home based preterm care through technology, which paves way to scale up the model across the countries. 目的 为了评估基于手机健康的早产儿家庭护理计划( mHealthPHCP )的被称为“NeoRaksha”的手机健康应用在改善亲子互动、早产儿生长发育方面的有效性,将描述一项随机对照试验方案。 设计 前瞻性随机对照临床试验。该方案于2016年8月2日获得印度政府生物技术部的批准和资助。 方法 总共将招募300对在三级护理医院新生儿重症监护病房住院的早产儿母亲及其孩子,并随机分配为干预组和对照组。干预组将接受基于手机健康的早产儿家庭护理计划,而对照组将接受标准的早产儿护理。干预小组将在家中由被称为公认的社会健康积极分子的社区健康工作者跟进,这些工作者将接受使用NeoRaksha手机医疗应用的培训。在医院随访期间将评估早产儿的效果。 讨论 支持早产儿护理的连续性是至关重要的,因为父母和早产儿都经历了从新生儿重症监护室过渡到他们家的时期。通过将手机技术融入医疗保健,可以增强母亲和社区健康工作者的能力,也有助于促进早产儿的健康,促进发展的效果和后续行动,进而减少与早产相关的死亡率、发病率和残疾率。 影响 这项研究的结果可以为通过技术整合医院和家庭早产儿护理开辟新的视野,这为在各国推广这一模式铺平了道路。