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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872569
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Claire Z. Kalpakjian, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Pregnancy Related Behavioral: Decision-making tool Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
Actual Study Start Date : July 28, 2021
Actual Primary Completion Date : May 11, 2022
Actual Study Completion Date : May 11, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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".

  2. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872569


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48170
Sponsors and Collaborators
University of Michigan
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: Claire Kalpakjian, PhD, MS University of Michigan
More Information
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Responsible Party: Claire Z. Kalpakjian, Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation, University of Michigan
ClinicalTrials.gov Identifier: NCT04872569    
Other Study ID Numbers: HUM00194755
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claire Z. Kalpakjian, University of Michigan:
Decision tool
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System