Assessing Function in Pediatric Patients With Sickle Cell Disease

NCT00590148 | Completed

• 1 other identifier: 07-163
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• FIM score

  Daily

Secondary Outcomes (1)

• Adolescent Pediatric Pain Tool (APPT) body outline score

  Daily

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 and adolescents with sickle cell disease

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (2)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• William T Zempsky, MD

  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: December 27, 2007
• First Posted: January 10, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (2)