The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00885976
First received: April 20, 2009
Last updated: June 25, 2013
Last verified: June 2013

April 20, 2009
June 25, 2013
September 2011
February 2012   (final data collection date for primary outcome measure)
  • Heath-related quality of life [ Time Frame: Baseline at time of initial outpatient clinic visit ] [ Designated as safety issue: No ]
    PedsQLTM 4.0 and 36-Item Short-Form Health Survey Version 2 (SF-36v2)
  • Pain intensity and functional disability [ Time Frame: Baseline at the time of initial outpatient clinic visit ] [ Designated as safety issue: No ]
    Pediatric Pain Questionnaire (PPQ) and Functional Disability Inventory (FDI)
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Complete list of historical versions of study NCT00885976 on ClinicalTrials.gov Archive Site
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The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain
The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain

This study is intended to provide additional insight into the factors affecting health-related quality of life with pediatric chronic pain as perceived by the patient versus his or her parents.In doing so, additional insight into the subjective interpretation the pediatric chronic pain experience will be gained. The four objectives of this study will be (a) to examine further the relationship between patient self-reported health-related quality of life and parent proxy-reported health-related quality; (b) to identify what biological, psychological, and/or social factors are the strongest predictors of a pediatric chronic pain patient's self-reported pain intensity and self-reported health-related quality of life, in a diverse cohort of patients referred to and subsequently treated by an anesthesiology-based yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and health-related quality of life; and (d) to determine the effect of patient/parental satisfaction with on-going health care on their compliance with and uptake of the pain treatment regimen.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants will come from those patients evaluated and treated in the Pediatric Chronic Pain Medicine Clinic at the Children's Hospital facilities. The likely study population includes essentially the pediatric population of the entire state of Alabama and immediately adjacent states (i.e., the geographic catchment area of the Children's Hospital of Alabama).

Pediatric Chronic Pain
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Vetter TR, Bridgewater CL, McGwin G Jr. An observational study of patient versus parental perceptions of health-related quality of life in children and adolescents with a chronic pain condition: who should the clinician believe? Health Qual Life Outcomes. 2012 Jul 23;10:85. doi: 10.1186/1477-7525-10-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • outpatients ranging between 8 years and 18 years of age directly referral from either their primary care physician or another specialist physician

Exclusion Criteria:

  • patients in whose biologic families English is not the primary, native language
  • patients suffering from severe cognitive dysfunction (i.e., mental retardation)
  • patients with a life-expectancy of less than three months at the time of initial clinical evaluation
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00885976
F081114005
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Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham
University of Alabama at Birmingham
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Principal Investigator: Thomas R. Vetter, MD, MPH University of Alabama at Birmingham
University of Alabama at Birmingham
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP