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

NCT04872569 | Completed Results

• 1 other identifier: HUM00194755
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Pregnancy Related

Keywords

Decision tool

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Feasibility - Acceptability

  12 weeks

• Feasibility - Demand

  12 weeks

• Feasibility - Ease of Use

  12 weeks

Study Arms (1)

Decision-making tool

EXPERIMENTAL

Women will receive the decision making tool and use for a 3 month period.

Behavioral: Decision-making tool

Interventions

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.

Decision-making tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- No plans for getting pregnant

Sponsors & Collaborators

• University of Michigan: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48170, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Claire Kalpakjian
• Organization: University of Michigan

clairez@umich.edu

734-763-0153

Study Officials

• Claire Kalpakjian, PhD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: July 28, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)