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临床试验/NCT02843022
NCT02843022已完成不适用

Enhancing Follow-up Mechanisms for Women at Risk for Postpartum Depression

Saint Anselm College1 个研究点 分布在 1 个国家目标入组 683 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
683
试验地点
1
主要终点
postpartum depression symptoms

研究概览

简要总结

The purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.

详细描述

The purpose of this randomized, controlled trial is to determine whether receiving standardized messages (text or email) from a postpartum nurse four times/week for 6 months after delivery will decrease symptoms of postpartum depression and parenting stress. Enrolled women will be randomized to one of three groups. The first group will receive the usual care, which is a phone call from a nurse within the first few weeks postpartum. The second group will receive four standardized messages each week, the content of which will include infant care, maternal self-care and inspirational material. The third group will receive the same four standardized messages each week, and in addition, two of these weekly messages will offer the option to respond with a request for a nurse to call them. Baseline data will be collected during the postpartum hospitalization, and follow-up will occur by email at 3 weeks, 3 months and 6 months postpartum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Able to speak and read English
  • •Access to a device which can receive text or email messages

排除标准

  • •Non-English speaking,
  • •No access to a device which can receive text or email messages
  • •Age younger than 18 -

研究组 & 干预措施

Usual care

Active Comparator

Participant will receive the usual care provided by the nursing staff at Catholic Medical Center. A lactation consultant or childbirth educator attempts to call each patient within 2-3 weeks prior to discharge. Only one call is made, and a message left if the patient would like to call back.

干预措施: Staff nurse phone follow-up (Behavioral)

Message Only

Experimental

Participant will receive the usual care, and in addition, will receive four standardized electronic messages weekly for six months postpartum. These will be one-way messages without the option to respond.

干预措施: standardized electronic messages (Behavioral)

Message Only

Experimental

Participant will receive the usual care, and in addition, will receive four standardized electronic messages weekly for six months postpartum. These will be one-way messages without the option to respond.

干预措施: Staff nurse phone follow-up (Behavioral)

Message and Nurse

Experimental

Participant will receive the usual care as well as the four standardized electronic messages/week for 6 months. Two of these weekly messages will be two-way, providing the option for the participant to respond "yes" to an offer to have a nurse call them. A nurse phone call if requested will be provided with a week.

干预措施: standardized electronic messages (Behavioral)

Message and Nurse

Experimental

Participant will receive the usual care as well as the four standardized electronic messages/week for 6 months. Two of these weekly messages will be two-way, providing the option for the participant to respond "yes" to an offer to have a nurse call them. A nurse phone call if requested will be provided with a week.

干预措施: nurse phone call if requested (Behavioral)

Message and Nurse

Experimental

Participant will receive the usual care as well as the four standardized electronic messages/week for 6 months. Two of these weekly messages will be two-way, providing the option for the participant to respond "yes" to an offer to have a nurse call them. A nurse phone call if requested will be provided with a week.

干预措施: Staff nurse phone follow-up (Behavioral)

结局指标

主要结局

postpartum depression symptoms

时间窗: 6 months postpartum

Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points

次要结局

  • Parenting stress(6 months postpartum)
  • breastfeeding outcomes(6 months postpartum)
  • patient satisfaction/experience(6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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