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

Not Applicable

Completed

• Conditions: Disability Physical
• Interventions: Behavioral: Decision-making tool

• Registration Number: NCT04651114
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-03
• Study Start: 2020-12-11
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Results First Submitted: 2022-05-12
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Results First Posted: 2022-07-14
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• 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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision-making tool	Decision-making tool	Women will receive the decision making tool and use for a 3 month period.

Primary Outcome Measures

Name	Time	Method
Final Decisional Conflict Scale Score - Values Clarity Sub-scale	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility - Acceptability	12 weeks	Acceptability of decision making tool is refers to whether the intervention is agreeable or satisfactory. In this study we measured this by self-report. We used 11 items that measured the presentation of information of the tool rated on Likert scales ranging from 1 (poor) to 4 (excellent) which are summed across all items. Possible scores can range from 11 to 44, with higher scores reflecting better information presentation.
Feasibility - Ease of Use	12 weeks	Ease of use refers to how easy an intervention is to use. In this study, we measures ease of use of the tool with a self-report, single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy). A higher rating means the tool was considered easier to use.
Feasibility - Demand	12 weeks	Demand refers to the likelihood of using an intervention after the study is over. For this study, it is a single item rated on Likert scales of 1 (definitely not likely) to 5 (very likely). Higher scores indicate a higher likelihood of using the tool after the study is over.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States