Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Completed

• Conditions: Sickle Cell Disease; Pain

• Registration Number: NCT01058473
• Lead Sponsor: Connecticut Children's Medical Center

Brief Summary

Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.

The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.

Detailed Description

Refer to Brief Summary

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-28
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Documented sickle cell disease
• Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.
• Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization
• Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
• Parental/patient consent and child assent

Exclusion Criteria

• Primary diagnosis other than vasoocclusive pain
• Concurrent Acute Chest Syndrome (ACS)
• Patient previously enrolled in this study
• Inability to understand English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IPPAQ	1 day	This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States