Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Pregnancy Related
• Interventions: Behavioral: Decision-making tool

• Registration Number: NCT04872569
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.

Detailed Description

The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.

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: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-07-28
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-04
• Results First Submitted: 2023-04-13
• Results First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Results First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Spinal cord injury (traumatic or non-traumatic)
• Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible
• 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

• No plans for getting pregnant

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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 - 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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 13 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 13 to 52, 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.

Trial Locations

Locations (1)

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