Scoliosis Survey to Development Treatment Decision Tool

December 13, 2023 updated by: Todd A. Milbrandt, M.D., Mayo Clinic

Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and Their Families

This is a survey to help understand the influences related to the decision for Adolescent Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then plans to create a decision aid to help families when making a decision about the treatment choice being presented to them.

Study Overview

Detailed Description

This survey is designed to help understand the factors that families consider to help make treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then be used to help create a shared decision making tool to help families better understand the treatment options and optimize clinical conversations surrounding AIS treatment.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolecent Idiopathic Scoliosis (AIS) patients and their families

Description

Inclusion Criteria:

  • Subject (and/or parent of subject) who has previously been treated for Adolescent Idiopathic Scoliosis (AIS)

Exclusion Criteria:

  • Age less than or equal to 12 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects who completed the survey
Time Frame: Baseline, approximately 3 years
Number of subjects who completed the survey
Baseline, approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Todd A Milbrandt, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimated)

January 11, 2017

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 16-008212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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