Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
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|ClinicalTrials.gov Identifier: NCT04872569|
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : May 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Pregnancy Related||Behavioral: Decision-making tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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).
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- No plans for getting pregnant
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
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48170|
|Principal Investigator:||Claire Kalpakjian, PhD, MS||University of Michigan|
|Responsible Party:||Claire Z. Kalpakjian, Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation, University of Michigan|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System