Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Michigan
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Final Decisional Conflict Scale Score - Values Clarity Sub-scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Claire Z. Kalpakjian
Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation
University of Michigan
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
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
- Feasibility - Demand(12 weeks)
- Feasibility - Acceptability(12 weeks)
- Feasibility - Ease of Use(12 weeks)