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

Overview

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.

Full Title of Study: “Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Decision-making tool
    • Women will receive the decision making tool and use for a 3 month period.

Clinical Trial Outcome Measures

Primary Measures

  • Change in the readiness to make a choice in Stage of Decision-Making Scale
    • Time Frame: Baseline, Up to 3 months
    • Decision or choice predisposition about pregnancy. The single-item scale ranges from “haven’t begun to think about choices” to “have already made a decision and unlikely to change my mind”.
  • Change in the Decisional Conflict Scale Score
    • Time Frame: Baseline, Up to 3 months]
    • Decisional conflict is characterized by uncertainty about a decision. The Decisional Conflict Scale consists of 9 items with 5 response options. Total scores range from 0 (no decisional conflict) to 45 (extremely high decisional conflict).

Secondary Measures

  • Acceptability of decision making tool as assessed by participant rating of the presentation of information
    • Time Frame: 3 months
    • Acceptability of decision making tool is measured by 11 items that measure the presentation of information are rated on Likert scales ranging from 1 (poor) to 4 (excellent) with higher scores reflecting better information presentation
  • Acceptability of decision making tool as assessed by participant rating by the usefulness in supporting decision making
    • Time Frame: 3 months
    • Acceptability is measured by 9 items. The items measure the usefulness of worksheets in the decision making tool and are rated on Likert scales ranging from 1 (not at all useful) to 5 (very useful). Higher scores indicate an increase in usefulness.
  • Demand of decision making tool as assessed by duration of intervention use
    • Time Frame: up to 3 months
    • Tracking usage through web statistics (i.e. site traffic and length of stay on the webpage)
  • Demand of decision making tool as measured by question on likeliness of using the tool after the study is over
    • Time Frame: up to 3 months
    • This is measured with 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.
  • Implementation of decision making tool as measured by question of ease of use of tool
    • Time Frame: 3 months
    • Implementation is measured with a single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy).

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • The Craig H. Neilsen Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claire Z. Kalpakjian, Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation – University of Michigan
  • Overall Official(s)
    • Claire Kalpakjian, PhD, MS, Principal Investigator, University of Michigan
  • Overall Contact(s)
    • Gina Jay, PhD, 734-763-9773, ginajay@umich.edu

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