跳至主要内容
临床试验/NCT05328622
NCT05328622已完成不适用

Rewarding Healthy Behaviors in Pregnancy and Postpartum With Aqueduct

Transcendent International, LLC1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年7月12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
发起方
入组人数
27
试验地点
1
主要终点
Percentage of eligible target population who consent to participate

研究概览

简要总结

This is a single-arm pilot clinical trial with two primary research goals:

  1. To test the efficacy of a software's ability to profile eligible individuals who decline participation in a clinical trial ("non-consenters") so that research staff may improve recruitment strategies for subsequent waves of potential participants.
  2. To test the feasibility of using the software's contingency management program in a population of pregnant persons in their third trimester of pregnancy.

详细描述

The first aim of the study is to test the feasibility of using a software program to incentivize pregnant patients to adhere to their prescribed prenatal appointments, postnatal appointment, and healthy behaviors. Participants will receive daily text messages that encourage engagement with health behaviors, and then participants earn points when they attend their scheduled appointments, bring in prescribed monitoring logs, and take their medications as prescribed.

A related aim of the study is to examine the effectiveness of the software system in providing support to researchers in implementing targeted participant recruitment in a manner that is labor-efficient and sustainable. The study will determine the efficacy of the software for (1) using psycho-demographic data to achieve more representative enrollment vis-à-vis target populations and (2) iteratively tailoring outreach materials and communication techniques based on actionable insights about those who participate and those who decline to participate.

研究设计

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

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant in third trimester of pregnancy
  • •Between 18 and 52 years of age
  • •Able to read and speak either English or Spanish
  • •A patient at Mount Sinai Hospital's OB-Gyn Ambulatory E-Level Clinic

排除标准

  • •Not pregnant (or no longer pregnant)
  • •Outside of age range
  • •Unwilling or unable to complete surveys
  • •Not a patient at the clinic of interest

研究组 & 干预措施

Adherence Incentives Program

Experimental

The intervention administered to participants is an incentive program designed to motivate participants to attend to/adhere to their prescribed prenatal course of care via the Aqueduct platform.

干预措施: Aqueduct Contingency Management Platform (Behavioral)

结局指标

主要结局

Percentage of eligible target population who consent to participate

时间窗: 4 months

Using descriptive statistics from recruitment, the investigators will determine whether the percentage (%) of eligible individuals from the population of pregnant women in their third trimester receiving prenatal care at the Mt. Sinai E-Level OB Clinic who elected to participate in the study increases between Wave 1 and Wave 2 of recruitment based upon changes in recruitment language.

Percentage of prenatal appointments attended

时间窗: 4 months

Using data from Mt. Sinai's electronic medical record appointment tracking system, the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased attendance at scheduled prenatal visits compared with baseline data in the clinic about attendance rates.

Percentage of postpartum appointments attended

时间窗: 4 months

Using data from Mt. Sinai's electronic medical record appointment tracking system, the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased attendance at scheduled postpartum visits compared with baseline data in the clinic about attendance rates.

次要结局

  • Changes in healthy eating between baseline and follow-up(4 months)
  • Changes in exercise habits between baseline and follow-up(4 months)
  • Changes in self-efficacy between baseline and follow-up(4 months)

研究者

发起方
Transcendent International, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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