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临床试验/NCT04636398
NCT04636398已完成不适用

Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Satisfied or Very Satisfied About Their Overall Intervention Experience

研究概览

简要总结

This study is a six-week exploratory developmental phase (phase 1) of a larger project to develop an mHealth intervention targeting health education and social support for Indian women in the postnatal period. Phase 1 of the trial exposes study participants to various intervention modalities and seeks to understand their experiences and perspectives on these using mixed-methods. Results from this trial will inform modifications to the intervention to be tested in Phase 2.

详细描述

Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage will include Phase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To develop optimal intervention functions, processes, and mHealth platforms for education and peer support among postnatal women in rural India. In Phase 1, the investigators will explore potential interactive education and peer support group intervention functions (education, emotional support, instrumental support, referrals, linkages, follow-up on postnatal visits), processes (group interactions; frequency, length and timing of groups; engagement opportunities, participant profiles) and mHealth delivery platforms (voice, text chat, app options, interaction features). This six-week developmental component will include up to four groups (n=48; 12 per group) to assess different modalities and functions. The investigators will ascertain women's preferences for functions, processes, and platform features using survey and in-depth interviews (IDIs), and capture levels of engagement via back-end data. This process will also inform the intervention's health information content. Findings will be used to formalize the group mobile intervention details to be examined in Phase 2.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Postnatal (within 2 weeks)
  • 18+ years old

排除标准

  • Women below 18 years of age
  • Women with high risk pregnancies
  • Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week

结局指标

主要结局

Satisfied or Very Satisfied About Their Overall Intervention Experience

时间窗: 6 weeks

Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six weeks.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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