Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT01959958
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Descriptive group characteristics of sickle cell disease participants with and without nocturnal enuresis', 'timeFrame': 'Once at or near enrollment', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Frequency of behavioral interventions', 'timeFrame': 'Once at or near enrollment', 'description': '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).'}, {'measure': 'Barriers to the use of interventions to prevent nocturnal enuresis', 'timeFrame': 'Once at or near enrollment', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nocturnal enuresis', 'Barriers to treatment'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSECONDARY OBJECTIVE: To identify barriers to intervention implementation for nocturnal enuresis.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with sickle cell disease and their parents/guardians', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CHARACTERISTICS:\n\n* Child Characteristics:\n\n * St. Jude Children's Research Hospital (SJCRH) patient with a primary diagnosis of sickle cell disease (HbSS, HbSC, HbSβ0thalassemia, HbSβ+thalassemia)\n * Age 6.0-17.99 years at the time of enrollment\n * Primary language is English\n * Has the cognitive capacity to complete questionnaires\n* Caregiver Characteristics:\n\n * Parent or guardian of SJCRH patient who meets above criteria\n * Primary language is English\n * Has the cognitive capacity to complete questionnaires\n\nEXCLUSION CRITERIA:\n\n* Child Characteristics:\n\n * 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).\n* Caregiver Characteristics:\n\n * Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection."}, 'identificationModule': {'nctId': 'NCT01959958', 'briefTitle': 'Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'PEESC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sickle cell disease', 'description': 'In this study, children and adolescents with sickle cell disease ages 6-18 years and their parents/guardians will complete a questionnaire/interview.', 'interventionNames': ['Other: Questionnaire/Interview']}], 'interventions': [{'name': 'Questionnaire/Interview', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Sickle cell disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Jerlym Porter, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}