Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities

NCT04651114 | Completed Results

• 2 other identifiers: HUM00189778R21HD092526
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to develop, and pilot test a decision-making tool that is tailored for women with physical disabilities to support those women in making a decision about whether or not a pregnancy is right given the participant's situation.

Conditions

Disability Physical

Keywords

Medical decision making; Pregnancy, planned

Outcome Measures

Primary Outcomes (4)

• Final Decisional Conflict Scale Score - Values Clarity Sub-scale

  The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Values Clarity sub-scale refers to how much a respondent is clear about the values that guide their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater clarity of values.

  12 weeks

• Final Decisional Conflict Scale Score - Support Sub-scale

  The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Support for Decision Making sub-scale refers to how much support a respondent has from others about their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater support for decision-making.

  12 weeks

• Final Decisional Conflict Scale Score - Uncertainty Sub-scale

  The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Uncertainty about the decision sub-scale refers to how much a respondent is uncertain about the decision. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater certainty about the decision.

  12 weeks

• Final Readiness to Make a Choice in Stage of Decision-Making Scale

  The Stage of Decision Making is a single item self-report measure. The options range from "haven't begun to think about choices" to "have already made a decision and unlikely to change my mind". The instructions were modified to refer to pregnancy and excluded the first two options of not having begun to think about choices given inclusion criteria. For this study, the scale ranged from 1 (are considering the decision now) to 4 (have already made a decision and am unlikely to change my mind). A higher score reflects greater readiness to make a decision.

  12 weeks

Secondary Outcomes (3)

• Feasibility - Acceptability

  12 weeks

• Feasibility - Demand

  12 weeks

• Feasibility - Ease of Use

  12 weeks

Study Arms (1)

Decision-making tool

EXPERIMENTAL

Women will receive the decision making tool and use for a 3 month period.

Behavioral: Decision-making tool

Interventions

Decision-making tool BEHAVIORAL

Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.

Decision-making tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical disability, defined by loss or impairment of physical function limiting one or more important life activities
• Mild, moderate or severe disability severity; severity will be assessed based on the need for assistance with daily life activities and/or personal care
• Actively planning or in the process of making a decision about whether or not to get pregnant in the near future.

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Dr. Claire Kalpakjian
• Organization: University of Michigan

clairez@umich.edu

734-763-0153

Study Officials

• Claire Kalpakjian, PhD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A pre-post design was selected for feasibility and preliminary efficacy.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: December 11, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: July 14, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)