跳至主要内容
临床试验/NCT04651114
NCT04651114已完成不适用

Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities

University of Michigan1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年12月11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
38
试验地点
1
主要终点
Final Decisional Conflict Scale Score - Values Clarity Sub-scale

研究概览

简要总结

The purpose of this project is to develop, and pilot test a decision-making tool that is tailored for women with physical disabilities to support those women in making a decision about whether or not a pregnancy is right given the participant's situation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Physical disability, defined by loss or impairment of physical function limiting one or more important life activities
  • Mild, moderate or severe disability severity; severity will be assessed based on the need for assistance with daily life activities and/or personal care
  • Actively planning or in the process of making a decision about whether or not to get pregnant in the near future.

排除标准

  • 未提供

研究组 & 干预措施

Decision-making tool

Experimental

Women will receive the decision making tool and use for a 3 month period.

干预措施: Decision-making tool (Behavioral)

结局指标

主要结局

Final Decisional Conflict Scale Score - Values Clarity Sub-scale

时间窗: 12 weeks

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Values Clarity sub-scale refers to how much a respondent is clear about the values that guide their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater clarity of values.

Final Decisional Conflict Scale Score - Support Sub-scale

时间窗: 12 weeks

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Support for Decision Making sub-scale refers to how much support a respondent has from others about their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater support for decision-making.

Final Readiness to Make a Choice in Stage of Decision-Making Scale

时间窗: 12 weeks

The Stage of Decision Making is a single item self-report measure. The options range from "haven't begun to think about choices" to "have already made a decision and unlikely to change my mind". The instructions were modified to refer to pregnancy and excluded the first two options of not having begun to think about choices given inclusion criteria. For this study, the scale ranged from 1 (are considering the decision now) to 4 (have already made a decision and am unlikely to change my mind). A higher score reflects greater readiness to make a decision.

Final Decisional Conflict Scale Score - Uncertainty Sub-scale

时间窗: 12 weeks

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Uncertainty about the decision sub-scale refers to how much a respondent is uncertain about the decision. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater certainty about the decision.

次要结局

  • Feasibility - Acceptability(12 weeks)
  • Feasibility - Ease of Use(12 weeks)
  • Feasibility - Demand(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claire Z. Kalpakjian

Associate Professor

University of Michigan

研究点 (1)

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