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

NCT ID: NCT04872569

Last Updated: 2024-01-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2022-05-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Decision-making tool

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

Group Type EXPERIMENTAL

Decision-making tool

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Claire Z. Kalpakjian

Associate Chair, Department of Physical Medicine and Rehabilitation and Associate Professor of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Kalpakjian, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUM00194755

Identifier Type: -

Identifier Source: org_study_id

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