Long-term Outcomes and Life Satisfaction of Adults With P... | NCT00876837

Studies
Long-term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries

NCT00876837

Sponsor

Shriners Hospitals for Children

Status

Completed

Last Update Posted

Aug 26, 2020Actual

Enrollment

514Actual

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

Aug 25, 2020Actual

Completion Date

Aug 25, 2020Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2020

Last Update Posted Date

Aug 26, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kathy Zebracki, Director of Psychology, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess life satisfaction and long-term outcomes (i.e., medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or adolescents.

Detailed Description

The ultimate goal of rehabilitation for children and adolescents with spinal cord injuries (SCIs) is to assure that they can grow up to have as productive and satisfying lives as their peers. Understanding factors associated with these outcomes of our patients after they have become adults may help to identify interventions and rehabilitation strategies that will optimize long-term outcomes. Long-term studies of adults with pediatric-onset SCI are needed to identify important outcomes, including survival, participation, health status and health-related quality of life, and life-satisfaction. Further, these outcomes need to be compared to population norms. Predictive models of important outcomes will be developed using independent factors, including demographic, impairment, functional limitation, participation, and environmental and personal factors. In addition, the impact of age at injury, upper extremity reconstruction or functional electrical stimulation implants, and the Mitrofanoff procedure on adult outcomes will be assessed. The stability of selected outcomes in comparison to normative and census data will be determined and factors associated with changes in these outcomes will be assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

514Actual

Label	Type	Description	Intervention Names
Adults with pediatric-onset SCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
medical complications	Assessment of medical complications, including pressure ulcers, spasticity, UTIs, hospitalizations	annually

Secondary Outcomes

Measure	Description	Time Frame
psychological outcomes	assessment of current psychological functioning, including depression, anxiety, happiness, and life satisfaction	annually

Other Outcomes

Measure	Description	Time Frame
social outcomes	assessment of social outcomes, including marriage, children, education level, employment status.	annually

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals who are 19 years of age and older
Were injured at the age of 18 years or younger
Received care at Shriners Hospitals for Children in Chicago, Philadelphia, or Northern California

Exclusion Criteria:

Non-English speaking individuals due to lack of measures in languages other than English and lack of foreign-speaking research assistants
severe brain injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The subjects for this study are adults who have received care in the SCI Programs of the Shriners Hospitals in Chicago, Philadelphia, or Northern California, who are 19 years of age and older and who were injured at age 18 years or younger.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathy Zebracki, Ph.D.	Shriners Hospitals for Children	Principal Investigator
Lawrence Vogel, M.D.	Shriners Hospitals for Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospitals for Children		Chicago	Illinois	60707	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31700146	Background	Deane KC, Chlan KM, Vogel LC, Zebracki K. Use of Appraisals of DisAbility Primary and Secondary Scale-Short Form (ADAPSS-sf) in individuals with pediatric-onset spinal cord injury. Spinal Cord. 2020 Mar;58(3):290-297. doi: 10.1038/s41393-019-0375-0. Epub 2019 Nov 7.
15503711	Result	Anderson CJ, Vogel LC, Betz RR, Willis KM. Overview of adult outcomes in pediatric-onset spinal cord injuries: implications for transition to adulthood. J Spinal Cord Med. 2004;27 Suppl 1:S98-106. doi: 10.1080/10790268.2004.11753545.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System