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Completed

NCT Number: NCT04872569

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48170, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • No plans for getting pregnant

Treatment and study plan

Decision-making tool

Behavioral

Participants will be directed to use the decision tool for 3 months using it at their own pace.

The tool covers topics relevant to women with disabilities in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.

Primary outcomes

  1. Final Decisional Conflict Scale Score - Values Clarity Sub-scale

    Time frame: 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.

  2. Final Decisional Conflict Scale Score - Support Sub-scale

    Time frame: 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.

  3. Final Decisional Conflict Scale Score - Uncertainty Sub-scale

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Feasibility - Acceptability

    Time frame: 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.

  2. Feasibility - Demand

    Time frame: 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.

  3. Feasibility - Ease of Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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