Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease

Completed

• Conditions: Sickle Cell Disease
• Interventions: Other: Questionnaire/Interview

• Registration Number: NCT01959958
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal enuresis (bedwetting) compared to the general population. This increased risk has been attributed to a decreased ability to concentrate urine caused by sickling-induced nephropathy. The sociodemographic, psychosocial, and medical factors associated with nocturnal enuresis are not well defined. In addition, the impact of these behaviors on emotional and behavioral functioning, along with health-related quality of life are not clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very few families with a child with sickle cell disease have utilized these methods. The reasons for this underutilization of interventions are not clear.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle cell disease	Questionnaire/Interview	In this study, children and adolescents with sickle cell disease ages 6-18 years and their parents/guardians will complete a questionnaire/interview.

Primary Outcome Measures

Name	Time	Method
Descriptive group characteristics of sickle cell disease participants with and without nocturnal enuresis	Once at or near enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of behavioral interventions	Once at or near enrollment	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).
Barriers to the use of interventions to prevent nocturnal enuresis	Once at or near enrollment	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).

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States