Back to resultsPilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
Primary Purpose
Spinal Cord Injuries, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision-making tool
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injuries focused on measuring Decision tool
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decision-making tool
Arm Description
Women will receive the decision making tool and use for a 3 month period.
Outcomes
Primary Outcome Measures
Change in the readiness to make a choice in Stage of Decision-Making Scale
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
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 Outcome Measures
Acceptability of decision making tool as assessed by participant rating of the presentation of information
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
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
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
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
Implementation is measured with a single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy).
Full Information
NCT ID
NCT04872569
First Posted
April 29, 2021
Last Updated
May 12, 2022
Sponsor
University of Michigan
Collaborators
The Craig H. Neilsen Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04872569
Brief Title
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
Official Title
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
The Craig H. Neilsen Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Pregnancy Related
Keywords
Decision tool
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision-making tool
Arm Type
Experimental
Arm Description
Women will receive the decision making tool and use for a 3 month period.
Intervention Type
Behavioral
Intervention Name(s)
Decision-making tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the readiness to make a choice in Stage of Decision-Making Scale
Description
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".
Time Frame
Baseline, Up to 3 months
Title
Change in the Decisional Conflict Scale Score
Description
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).
Time Frame
Baseline, Up to 3 months]
Secondary Outcome Measure Information:
Title
Acceptability of decision making tool as assessed by participant rating of the presentation of information
Description
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
Time Frame
3 months
Title
Acceptability of decision making tool as assessed by participant rating by the usefulness in supporting decision making
Description
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.
Time Frame
3 months
Title
Demand of decision making tool as assessed by duration of intervention use
Description
Tracking usage through web statistics (i.e. site traffic and length of stay on the webpage)
Time Frame
up to 3 months
Title
Demand of decision making tool as measured by question on likeliness of using the tool after the study is over
Description
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.
Time Frame
up to 3 months
Title
Implementation of decision making tool as measured by question of ease of use of tool
Description
Implementation is measured with a single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy).
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Kalpakjian, PhD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48170
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
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