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

NCT01058473 | Completed

• 1 other identifier: CCMC IRB Number 09-115
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Pain

Keywords

Sickle Cell Disease; Pain; Assessment

Outcome Measures

Primary Outcomes (1)

• IPPAQ

  This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.

  1 day

Study Arms (1)

Sickle Cell Disease

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents, and young adults with sickle cell disease.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William T. Zempsky, M.D.

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Relief Program

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (1)