- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017755
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Damian Paulson
- Phone Number: 507-293-6713
- Email: paulson.damian@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Natalie Pulido
- Email: scoliosis@mayo.edu
-
-
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.
Helpful Links
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
Additional Relevant MeSH Terms
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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