Clinical trial NCT01959958: Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease
Official title: Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Nocturnal enuresis
Barriers to treatment
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with sickle cell disease and their parents/guardians

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.

Eligibility 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.

Primary outcomes:
measure: Descriptive group characteristics of sickle cell disease participants with and without nocturnal enuresis
timeFrame: Once at or near enrollment
Secondary outcomes:
measure: Frequency of behavioral interventions
timeFrame: Once at or near enrollment
measure: Barriers to the use of interventions to prevent nocturnal enuresis
timeFrame: Once at or near enrollment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Jerlym Porter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: