Assessing Function in Pediatric Patients With Sickle Cell Disease

Assessing Function in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain Using the FIM Instrument

The purpose of this study is to evaluate the FIM™ as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain. Currently, the standard for pain assessment is a rating of pain intensity, as determined by observation (for younger children) or self-report (for older children and adolescents). However, these measures of pain intensity are not effective in recurrent or chronic pain states, and in sickle cell disease in particular. Pediatric patients who are hospitalized with vasoocclusive pain often do not report a decrease in pain intensity; however, other indications of clinical status, such as ambulation, less use of opiates from the patient-controlled analgesia (PCA) pump, increased food intake, and transition to oral pain medication, signify that the patient may be improving. As a result of our inability to get an accurate picture of the patients' condition, we would like to have a summary of improvement that would reflect these changes in clinical status and reflect the reduced impact of sickle cell pain on the patient's life. In this study, we plan to evaluate a standardized functional assessment measure in pediatric patients with sickle cell disease. It is hypothesized that FIM™ scores will correlate with other indicators of clinical status, such as movement, quality of sleep, use of IV opiates from the patient-controlled analgesia (PCA) pump, and use of intravenous vs. oral pain medications. It is also hypothesized that the FIM™ will demonstrate adequate responsiveness to change in functional status within a 3-7 day hospitalization by a progressive increase in scores and associations with other indicators of clinical improvement.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with sickle cell disease

Description

Inclusion Criteria:

• Ages 7-21 years inclusive
• Documented sickle cell disease
• Sudden onset of pain consistent with vasoocclusive episode
• Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease
• Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
• Parental consent and child assent

Exclusion Criteria:

• Younger than 7 years old
• Primary diagnosis other than vasoocclusive pain
• Concurrent Acute Chest Syndrome (ACS)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FIM score	Daily

Secondary Outcome Measures

Outcome Measure	Time Frame
Adolescent Pediatric Pain Tool (APPT) body outline score	Daily

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: William T Zempsky, MD, Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: 07-163