Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT04228094
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment recommended/prescribed', 'timeFrame': '4 days', 'description': 'Treatment recommended/prescribed consists on the treatment recommended to the patient with ADHD by TDApp1 and the actual treatment prescribed by the investigator to this patient.'}], 'secondaryOutcomes': [{'measure': 'Patient/parent satisfaction with the participation in the health decision-making process', 'timeFrame': '3 weeks', 'description': 'Satisfaction of the patients or their parents with their participation in the health decision-making process. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.'}, {'measure': 'Patient/parent satisfaction with TDApp1', 'timeFrame': '3 weeks', 'description': 'The satisfaction of the patients or their parents with the educational material provided, and the usability and simplicity of TDApp1. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.'}, {'measure': 'ADHD symptom severity', 'timeFrame': '3 weeks', 'description': 'ADHD symptom severity will be assessed with the self-rated, 18-item, DSM V (in children and adolescents) or IV-TR (in adults) -based Rating Scale. Total score ranges from 0 to 54. Higher total scores indicate greater illness severity.'}, {'measure': 'Adverse events', 'timeFrame': '3 weeks', 'description': 'The incidence of adverse events will be collected by means of a questionnaire'}, {'measure': 'Patient/parent satisfaction with the treatment prescribed', 'timeFrame': '3 weeks', 'description': 'Satisfaction of the patients or their parents with the prescribed treatment. This outcome will be collected by means of visual analogic scale that has been developed for this study. Score ranges from 1 to 9. Higher scores indicate greater satisfaction.'}, {'measure': 'Physical activity', 'timeFrame': '3 weeks', 'description': 'The physical activity will be measured by means of ActiGraph wGT3X-BT that records continuous physical activity and sleep/wake information.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eHealth', 'evidence based medicine', 'machine learning'], 'conditions': ['Attention Deficit-hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This is a 3-week open label, one group study to determine the agreement between the pharmacological treatment recommended by TDApp1 and the interventions recommended by relevant clinical practice guidelines.', 'detailedDescription': 'Clinical practice guidelines (CPGP) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for patients with a mild disorder or for complex patients with comorbiditie. Another limitation is that patients involvement in CPGs development is still poor.\n\nWe aim to develop and assess TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder.\n\nA 3-week, one group, open label study will be conducted. Fifty-five patients aged 6-65 with ADHD will use TDApp1. The therapeutic recommendations made by the TDApp1 and by relevant CPG will be compared. Concordance in the recommendations will be studied. Effectiveness, safety, changes in physical activity and satisfaction will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ADHD patients will be recruited from specialiazed setting.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ages 6-65\n* A diagnosis of DSM-V ADHD based on clinical assessment\n\nExclusion Criteria:\n\n* Patients under adequate therapeutic treatment or requiring minor adjustments\n* Patients lacking an electronic device (mobile phone, tablet,...) with internet access'}, 'identificationModule': {'nctId': 'NCT04228094', 'briefTitle': 'Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Girona'}, 'officialTitle': 'Development and Assesment of TDApp1 an eHelath Tool to Make Participatory, Patient-centred and Automated Therapeutic Recommendations for Patients With Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'tdapp1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TDApp1', 'description': 'This cohort will use TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder', 'interventionNames': ['Other: TDApp1: an eHealth intervention']}], 'interventions': [{'name': 'TDApp1: an eHealth intervention', 'type': 'OTHER', 'description': 'TDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder', 'armGroupLabels': ['TDApp1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17003', 'city': 'Girona', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Institut d'Assitència Sanità ria", 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'overallOfficials': [{'name': 'Xavier Castells, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de Girona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Girona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Development of a web application to formulate participatory, individualized and automated therapeutic recommendations for the treatment of patients with ADHD', 'investigatorFullName': 'Xavier Castells', 'investigatorAffiliation': 'Universitat de Girona'}}}}