Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-30 @ 8:47 PM
Study NCT ID:
NCT05030961
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2021-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Team-based Virtual Pediatric Cochlear Implant Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrode Impedances', 'timeFrame': 'Up to 1 year', 'description': 'Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software'}, {'measure': 'Electrically evoked compound potential values', 'timeFrame': 'Up to 1 year', 'description': 'Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software'}, {'measure': 'Datalogging', 'timeFrame': 'Up to 1 year', 'description': 'Datalogging, reported in hours per week, will be extracted from the cochlear implant software'}, {'measure': 'Threshold/Upper stimulation levels', 'timeFrame': 'Up to 1 year', 'description': 'As measured from the cochlear implant software'}, {'measure': 'LittleEars questionnaire scores', 'timeFrame': 'Up to 1 year', 'description': 'The LittleEars auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance.'}, {'measure': 'Auditory Skills Checklist (ASC) scores', 'timeFrame': 'Up to 1 year', 'description': 'ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills'}], 'secondaryOutcomes': [{'measure': 'Behavior Assessment System for Children version 3 (BASC-3) scores', 'timeFrame': 'Up to 1 year', 'description': 'BASC-3 is scored 0-120 as a T score. Any scores between 60-70 is considered at risk / requires monitoring and scores greater than 70 are considered clinically significant / an area that likely requires therapeutic intervention.'}, {'measure': 'Patient Health Questionnaire version 8 (PHQ-8) scores', 'timeFrame': 'Up to 1 year', 'description': 'PHQ-8 has 8 items rated on a scale from "not at all" (0) to "nearly every day" (3), with higher scores indicating greater frequency of depressive symptoms. The sum of the items indicates the overall level of depressive symptoms indicating mild (5-9), moderate (10-14), moderately severe (15-19), and severe depressive symptoms (20- 24).'}, {'measure': 'Generalized Anxiety Disorder version 7 (GAD-7) scores', 'timeFrame': 'Up to 1 year', 'description': 'GAD-7 is a 7-item self-report questionnaire of anxiety symptomatology in the past 14 days. Respondents rate the frequency of each item during the past two weeks on a 0-3-point scale ranging from not at all (0) to nearly every day (3). The sum of the items indicates the overall level of anxiety symptoms indicating mild (0-4), moderate (5-9), moderately severe (10-14), and severe (15- 21).'}, {'measure': 'Quality of Life- CI (QoL-CI) scores', 'timeFrame': 'Up to 1 year', 'description': 'QoL-CI is scored 0-100 with higher scores indicating better quality of life.'}, {'measure': 'Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores', 'timeFrame': 'Up to 1 year', 'description': 'CIQOL-35 Profile is a 35 item questionnaire with a total score ranging from 0-100% with a higher score indicating a higher level of functional ability with a cochlear implant'}, {'measure': 'Parenting Stress Index/Short Form (PSI) scores', 'timeFrame': 'Up to 1 year', 'description': 'Parenting Stress Index/Short Form (PSI) contains 36 items rated on a 6-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree) and a total score. Higher scores indicate increased parenting stress.'}, {'measure': 'Parenting Stress-CI scores', 'timeFrame': 'Up to 1 year', 'description': 'Parenting Stress-CI is completed by the parent and scored from "not at all stressful" (0) to "very stressful" (3) with higher scores indicating greater degrees of parenting stress. For parents of children 0-5 years, there are 15 items. For parents of children 6-12 years there are 8 items.'}, {'measure': 'Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores', 'timeFrame': 'Up to 1 year', 'description': "The SPISE-R is comprised of 46 questions that uses a 7-point Likert scale to query parents' beliefs, knowledge, confidence, and actions relevant to supporting their child's auditory access and spoken language development. The total average score will range from 1 to 7 with 7 indicating the highest score / highest level of parental involvement and self efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNew patients undergoing CI evaluation:\n\n1. English speaking patients (parents can speak English and/or Spanish)\n2. Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process\n\nEstablished CI recipients:\n\n1. English speaking patients (parents can speak English and/or Spanish)\n2. Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity\n\nExclusion Criteria:\n\n1. Patients with families who speak languages other than English or Spanish\n2. Patients who do not live in Florida\n3. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements'}, 'identificationModule': {'nctId': 'NCT05030961', 'briefTitle': 'Team-based Virtual Pediatric Cochlear Implant Clinic', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants', 'orgStudyIdInfo': {'id': '20210584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric Cochlear Implant Candidate Group', 'description': 'Participants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year.', 'interventionNames': ['Behavioral: Virtual team-based clinic']}, {'type': 'EXPERIMENTAL', 'label': 'Established Cochlear Implant Recipient Group', 'description': 'Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.', 'interventionNames': ['Behavioral: Virtual team-based clinic', 'Behavioral: Remote cochlear implant programming']}], 'interventions': [{'name': 'Virtual team-based clinic', 'type': 'BEHAVIORAL', 'description': 'Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.', 'armGroupLabels': ['Established Cochlear Implant Recipient Group', 'Pediatric Cochlear Implant Candidate Group']}, {'name': 'Remote cochlear implant programming', 'type': 'BEHAVIORAL', 'description': 'Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.', 'armGroupLabels': ['Established Cochlear Implant Recipient Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Chrisanda M Sanchez, AuD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley J. Glaser Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chrisanda Sanchez', 'investigatorAffiliation': 'University of Miami'}}}}