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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Decision-making tool

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48170
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision-making tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Claire Kalpakjian, PhD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Decision tool
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: HUM00194755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No