Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05547958
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2022-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parents InformaTion in Child REHABilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017144', 'term': 'Focus Groups'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'key elements desired by parents in the apps aiming to share informations with rehabilitation professionals', 'timeFrame': 'june 2022 - june 2023', 'description': 'The aim is to identify the key priority elements for parents in the design of mobile apps for information exchange with rehabilitation professionals.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['m-health', 'mobile apps', 'chronic disease', 'informations', 'parents', 'pediatric', 'rehabilitation', 'communication'], 'conditions': ['Children with Chronic Condition']}, 'referencesModule': {'references': [{'pmid': '30171827', 'type': 'BACKGROUND', 'citation': 'Nussbaum R, Kelly C, Quinby E, Mac A, Parmanto B, Dicianno BE. Systematic Review of Mobile Health Applications in Rehabilitation. Arch Phys Med Rehabil. 2019 Jan;100(1):115-127. doi: 10.1016/j.apmr.2018.07.439. Epub 2018 Aug 29.'}, {'type': 'BACKGROUND', 'citation': 'Maguire M. Methods to support human-centred design. International Journal of Human-Computer Studies. 1 oct 2001;55(4):587-634.'}, {'pmid': '20851841', 'type': 'BACKGROUND', 'citation': "O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available."}, {'pmid': '23235644', 'type': 'BACKGROUND', 'citation': 'de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.'}]}, 'descriptionModule': {'briefSummary': "In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Paediatric rehabilitation care involves multidisciplinary team working closely with families. During follow-up rehabilitation, communication between the children, families and the professionals is essential. To this end, digital health solutions can be helpful.\n\nDigital health solutions are rapidly emerging in the field of paediatric rehabilitation. In this context of emergence of digital health solutions, it is essential to identify the needs and expectations of families of children with a chronic disease.\n\nThis project aims to identify the key points in terms of information exchange on rehabilitation monitoring. To identify these needs, a mixed study will be carried out from June 2022 to June 2023 involving focus groups to gather qualitative informations on parent's needs in terms of information exchange through digital apps and quantitative research with a survey that will allow to prioritise these needs.", 'detailedDescription': 'For the first part of the study, the researchers will conduct focus groups and interview parents about their experiences and perceptions of information exchange with rehabilitation professionals. All the participants will be parents of a child with a chronic disease, aged between 0 and 18 years and receiving paediatric rehabilitation care. The objective of this first part is to collect qualitative information on the needs of parents in terms of information exchange through digital applications.\n\nWith the analysis of the focus group, the researchers will define the hypothesis.\n\nThen, a survey will be built and shared online in France during 3 months (2nd semester 2022).\n\nWith this survey, the objective is to identify the key points for the development of paediatric rehabilitation apps in terms of information exchange.\n\nQuantitative data will be described with frequency, mean and standard deviation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents of a child (0-18 years) with a chronic condition and with a rehabilitation follow up will be invited by physicians in three pediatric rehabilitation centers to participate to the focus groups.\n\nThe survey will be adressed nationally to the parents of children with a chronic condition and with a rehabilitation follow up.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- parents of a child (0-18 years) with a chronic condition and with a rehabiilitation follow up\n\nExclusion Criteria:\n\n* parents who do not speak french\n* parents with an intellectual disability (for the first part : focus group)'}, 'identificationModule': {'nctId': 'NCT05547958', 'acronym': 'PITChREHAB', 'briefTitle': 'Parents InformaTion in Child REHABilitation', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Ildys'}, 'officialTitle': 'Parents InformaTion in Child REHABilitation', 'orgStudyIdInfo': {'id': 'IS-C4-2022-009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Focus group and online survey', 'type': 'OTHER', 'description': 'Focus group with parents of children with disabilities or chronic condition will be organized to identify hypotheses regarding their needs in terms of informations exchange with pediatric rehabilitation professionals about the rehabilitation care of their children.\n\nThen, an online survey will be proposed to parents of children with disabilities or chronic condition in France to identify their needs regarding the development of apps that offer the feature to share informations with rehabilitation professionals.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Fondation Ildys', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ildys', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Brest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}