NCT04872569

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

Completed NA Results posted Last updated 16 January 2024

What this trial tests

NA trial testing Decision-making tool in Spinal Cord Injuries in 23 participants. Completed in 11 May 2022.

Timeline

28 July 2021

Primary endpoint
11 May 2022

11 May 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	23
Start date	28 July 2021
Primary completion	11 May 2022
Estimated completion	11 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Decision-making tool

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

University of Michigan

Who can join

18 and older, female only, with Spinal Cord Injuries or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Final Decisional Conflict Scale Score - Values Clarity Sub-scale Primary · 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.

Group	Value	95% CI
Women Using Tool	13.4	± 1.6

Final Decisional Conflict Scale Score - Support Sub-scale Primary · 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.

Group	Value	95% CI
Decision Making Tool	13.1	± 2.0

Final Decisional Conflict Scale Score - Uncertainty Sub-scale Primary · 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.

Group	Value	95% CI
Decision Making Tool	11.8	± 3.3

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

Group	Value	95% CI
Decision Making Tool	3.19	± 1.1

Feasibility - Acceptability Secondary · 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.

Group	Value	95% CI
Decision Making Tool	38.96	± 6.5

Feasibility - Demand Secondary · 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.

Group	Value	95% CI
Decision Making Tool	3.43	± 1.1

Feasibility - Ease of Use Secondary · 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.

Group	Value	95% CI
Decision Making Tool	4.4	± 1.0

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury.
   Dietz VA, Roberts N, Knox K, Moore S, et al · · 2022 · cited 19× · PMID 36212690 · DOI 10.3389/fncel.2022.977679