An interventional study of Decision-making tool in Spinal Cord Injuries and Pregnancy Related, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by University of Michigan · Not applicable, Interventional, and Other
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 23 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women will receive the decision making tool and use for a 3 month period.
Behavioral: Decision-making tool
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.
Final Decisional Conflict Scale Score - Values Clarity Sub-scale
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.
Time frame: 12 weeks
Final Decisional Conflict Scale Score - Support Sub-scale
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.
Time frame: 12 weeks
Final Decisional Conflict Scale Score - Uncertainty Sub-scale
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.
Time frame: 12 weeks
Final Readiness to Make a Choice in Stage of Decision-Making Scale
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.
Time frame: 12 weeks
Feasibility - Acceptability
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.
Time frame: 12 weeks
Feasibility - Demand
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.
Time frame: 12 weeks
Feasibility - Ease of Use
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.
Time frame: 12 weeks
| Milestone | Decision-making Tool |
|---|---|
| Started | 23 |
| Completed | 21 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| units on a scale | Women Using Tool |
|---|---|
| Final Decisional Conflict Scale Score - Values Clarity Sub-scale | 13.4 ± 1.6 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Final Decisional Conflict Scale Score - Support Sub-scale | 13.1 ± 2.0 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Final Decisional Conflict Scale Score - Uncertainty Sub-scale | 11.8 ± 3.3 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Final Readiness to Make a Choice in Stage of Decision-Making Scale | 3.19 ± 1.1 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Feasibility - Acceptability | 38.96 ± 6.5 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Feasibility - Demand | 3.43 ± 1.1 |
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.
| units on a scale | Decision Making Tool |
|---|---|
| Feasibility - Ease of Use | 4.4 ± 1.0 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decision Making Tool | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Decision-making Tool |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 0 |
| Age, Continuous(years) | Decision-making Tool |
|---|---|
| Mean | 32.7 ± 6.0 |
| Sex: Female, Male(Participants) | Decision-making Tool |
|---|---|
| Count by sex — Female | 23 |
| Count by sex — Male | 0 |
| Race (NIH/OMB)(Participants) | Decision-making Tool |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Decision-making Tool |
|---|---|
| United States | 23 |
| Decisional Conflict Scale, Values Clarity sub-scale(units on a scale) | Decision-making Tool |
|---|---|
| Mean | 12.9 ± 1.7 |
| Decisional Conflict Scale, Support for Decision Making sub-scale(units on a scale) | Decision-making Tool |
|---|---|
| Mean | 12.1 ± 2.3 |
| Decisional Conflict Scale, Uncertainty about the Decision sub-scale(units on a scale) | Decision-making Tool |
|---|---|
| Mean | 9.9 ± 3.7 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Michigan