Validation of the Sickle Cell Disease Pain Burden Interview | NCT00804362

Studies
Validation of the Sickle Cell Disease Pain Burden Interview

NCT00804362

Sponsor

Connecticut Children's Medical Center

Status

Completed

Last Update Posted

Jul 30, 2013Estimated

Enrollment

131Actual

Phase

Not provided

Conditions

Sickle Cell Disease
Pain

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

Jul 2013

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

Dec 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

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

Jul 29, 2013

Last Update Posted Date

Jul 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical CenterPrincipal Investigator

Lead Sponsor

Connecticut Children's Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview (SCPBI), which can be used in the clinical and/or research settings to assess the impact of pain on children with sickle cell disease.

Detailed Description

Not provided

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

131Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation with validated measures of pain interference, function, quality of life, and mood.		Quarterly

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented sickle cell disease
7 years old or greater
Primary caregiver present at the first visit for children < 18 years of age

Exclusion Criteria:

Primary language spoken other than English
Patient is in acute pain episode at time of initial visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Children and adolescents diagnosed with sickle cell disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Connecticut Children's Medical Center		Hartford	Connecticut	06106	United States

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D010146	Pain

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided