- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01959958
Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE: To examine differences between those who do and those who do not exhibit nocturnal enuresis in regard to health-related quality of life, emotional and behavioral functioning, family functioning, stressful life events, sociodemographic factors and medical factors.
SECONDARY OBJECTIVE: To identify barriers to intervention implementation for nocturnal enuresis.
In this study, children and adolescents with sickle cell disease ages 6-18 years and their parents/guardians will each complete an interview with questionnaires assessing nocturnal enuresis, health-related quality of life, emotional and behavioral functioning, family functioning, and stressful life events. Participants who report nocturnal enuresis will identify interventions they have used in the past, along with barriers to intervention implementation.
The future goal will be to use this information to develop an effective intervention strategy for nocturnal enuresis specific to the needs of children and adolescents with sickle cell disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CHARACTERISTICS:
Child Characteristics:
- St. Jude Children's Research Hospital (SJCRH) patient with a primary diagnosis of sickle cell disease (HbSS, HbSC, HbSβ0thalassemia, HbSβ+thalassemia)
- Age 6.0-17.99 years at the time of enrollment
- Primary language is English
- Has the cognitive capacity to complete questionnaires
Caregiver Characteristics:
- Parent or guardian of SJCRH patient who meets above criteria
- Primary language is English
- Has the cognitive capacity to complete questionnaires
EXCLUSION CRITERIA:
Child Characteristics:
- Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever).
Caregiver Characteristics:
- Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sickle cell disease
In this study, children and adolescents with sickle cell disease ages 6-18 years and their parents/guardians will complete a questionnaire/interview.
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Participants will each complete an interview with questionnaires assessing nocturnal enuresis, health-related quality of life, emotional and behavioral functioning, family functioning, and stressful life events.
Participants who report nocturnal enuresis will also be asked to identify interventions they have used in the past, along with barriers to intervention implementation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive group characteristics of sickle cell disease participants with and without nocturnal enuresis
Time Frame: Once at or near enrollment
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Health-related quality of life, emotional and behavioral functioning, family functioning, stressful life events, sociodemographic factors and medical factors will be examined from questionnaire responses.
Classification will be based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR).
Data will be stratified by age (6-11 years and 12-18 years) and genotype (HbSS/ HbSβ0 thalassemia and HbSC/ HbSβ+ thalassemia).
The sample will be dichotomized using the binary response (by nocturnal enuresis/no nocturnal enuresis).
Pearson's chi-square or Fisher's Exact test for categorical data and the two-sample t-test for continuous data will be performed to examine the group differences.
Logistic regression will be performed using the binary response to examine the effect of these factors with covariates selected by Bayesian information criterion (BIC) with age group indicator and genotype included in the regression.
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Once at or near enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of behavioral interventions
Time Frame: Once at or near enrollment
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The total number of interventions used and the frequencies of the type interventions used will be calculated.
A summary will also be prepared for each age group (6-11 years and 12-18 years).
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Once at or near enrollment
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Barriers to the use of interventions to prevent nocturnal enuresis
Time Frame: Once at or near enrollment
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The number and frequencies of barriers to implementation of interventions will be assessed by a checklist of items (i.e., time, inconvenience, forgetfulness) and open-ended responses provided by participants.
A summary will also be prepared for each age group (6-11 years and 12-18 years).
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Once at or near enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Jerlym Porter, PhD, MPH, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Hematologic Diseases
- Genetic Diseases, Inborn
- Urination Disorders
- Anemia
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Elimination Disorders
- Urinary Incontinence
- Anemia, Sickle Cell
- Enuresis
- Nocturnal Enuresis
Other Study ID Numbers
- PEESC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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