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

Study Overview
=================
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.

Official Title
-----------------
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries, Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: Decision-making tool


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision-making tool<br>Women will receive the decision making tool and use for a 3 month period. | Behavioral: Decision-making tool<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Up to 3 months | 
| 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). | Baseline, Up to 3 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| 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. | 3 months | 
| 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) | up to 3 months | 
| 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. | up to 3 months | 
| 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). | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision tool