We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01959958
First Posted: October 10, 2013
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  Purpose
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.

Condition Intervention
Sickle Cell Disease Other: Questionnaire/Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Descriptive group characteristics of sickle cell disease participants with and without nocturnal enuresis [ Time Frame: 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:
  • Frequency of behavioral interventions [ Time Frame: 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 [ Time Frame: 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).


Enrollment: 250
Study Start Date: October 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Questionnaire/Interview
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.

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with sickle cell disease and their parents/guardians
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01959958


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Jerlym Porter, PhD, MPH St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01959958     History of Changes
Other Study ID Numbers: PEESC
First Submitted: October 8, 2013
First Posted: October 10, 2013
Last Update Posted: May 11, 2016
Last Verified: April 2016

Keywords provided by St. Jude Children's Research Hospital:
Nocturnal enuresis
Barriers to treatment

Additional relevant MeSH terms:
Anemia, Sickle Cell
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms