A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises
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|ClinicalTrials.gov Identifier: NCT02698761|
Recruitment Status : Terminated (Standard of care changed)
First Posted : March 4, 2016
Last Update Posted : May 3, 2018
Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to 90,000 individuals in the United States. There are 13,000 hospital admissions for a sickle cell crises, costing $448 million dollars annually. In our hospital, the sickle cell population is known to have some of the longest length of stays. Between October 2014 and September 2015, there were 89 admissions for a vaso-occlusive crisis with an average length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than 20 days.
We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease. We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain. We hypothesize increased physical activity and proper sleep, as implemented in the CPP, are correlated with decreased hospital length of stay and decreased pain. Additionally, we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Sickle Cell Crisis Vaso-Occlusive Crises||Other: Comprehensive Care Plan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
No Intervention: Standard of Care
Patient will receive standard of care. Subject will have an actiwatch to compare activity and sleep habits. Nursing staff will be aware of study presence but will not receive any specific instruction for the patient.
Experimental: Comprehensive Care Plan
Patient will abide by the comprehensive care plan and sign an agreement stating compliance. Subject will have an actiwatch to compare activity and sleep habits. Nursing staff will be notified of study and support patient's compliance with study procedures.
Other: Comprehensive Care Plan
- Length of Stay [ Time Frame: 2 Years ]Length of Stay in Days
- Pain Scores [ Time Frame: 2 Years ]pain scores assessed daily for each patient using the (Visual Analog Scale) VAS scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698761
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|