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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01058473
First received: January 26, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition
Sickle Cell Disease
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Resource links provided by NLM:


Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • IPPAQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.


Enrollment: 159
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sickle Cell Disease

Detailed Description:

Refer to Brief Summary

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058473

Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: William T. Zempsky, M.D. Connecticut Children's Medical Center
  More Information

No publications provided

Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT01058473     History of Changes
Other Study ID Numbers: CCMC IRB Number 09-115
Study First Received: January 26, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
Sickle Cell Disease
Pain
Assessment

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 24, 2014