{ "FullStudy":{ "Rank":218207, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511341", "OrgStudyIdInfo":{ "OrgStudyId":"SNSF-13DPD6_132135" }, "Organization":{ "OrgFullName":"University of Applied Sciences of Western Switzerland", "OrgClass":"OTHER" }, "BriefTitle":"Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases", "OfficialTitle":"Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial" }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 3, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 4, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Anne-Sylvie Ramelet", "ResponsiblePartyInvestigatorTitle":"Professor HES-S2", "ResponsiblePartyInvestigatorAffiliation":"University of Applied Sciences of Western Switzerland" }, "LeadSponsor":{ "LeadSponsorName":"University of Applied Sciences of Western Switzerland", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Swiss National Science Foundation", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Réseau d'Etudes aux Confins de la Santé et du Social (RECSS)(HES-SO)", "CollaboratorClass":"UNKNOWN" },{ "CollaboratorName":"University of Lausanne Hospitals", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Consultation Multisite Romande de Rhumatologie Pédiatrique", "CollaboratorClass":"UNKNOWN" },{ "CollaboratorName":"Ligue Genevoise contre le Rhumatisme", "CollaboratorClass":"UNKNOWN" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases of the locomotion system. The annual rate incidence of children diagnosed with rheumatic disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children experience a chronic course of the disease impacting on their quality of life and family functioning. Their medical treatment is significant and may last for life. Caring for these children involves a multidisciplinary approach. Control of the disease and management of the symptoms becomes of foremost importance to minimise disability and pain. In addition to medical care, the supporting role of nurses in the care of children with rheumatic diseases and their family aims to limit the potential for further deformity, disability, and psychological complications. In particular, they play a key role in supporting the specialist team caring for patients with rheumatism disease, recognising poor disease control and the need for changes in treatment, providing a resource to patients on treatment options and how to access additional support and advice, and identifying best practice to achieve optimal outcomes for the patients and their family. Nurses also ensure the link between medical practitioner, other health providers, and family, thus play a key role in the follow-up care of the child and its family. Follow-up of children and their family can be ensured by regular telephone consultation (telenursing) made by experienced nurse specialists in rheumatology. However, the effectiveness of telenursing remains to be proven in children with chronic rheumatic diseases. The aim of this study is, therefore, to evaluate the effect of a telephone nursing intervention on the outcomes of family and children with rheumatism chronic disease.\n\nThis randomised crossover, experimental longitudinal study will be carried out in the outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of Vaud. The population will consist of children newly diagnosed with inflammatory rheumatologic diseases and one of their parent. The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Inflammatory Rheumatism" ] }, "KeywordList":{ "Keyword":[ "Telenursing", "Children", "Chronic Illness", "Nursing" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"55", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Telenursing", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Telenursing" ] } },{ "ArmGroupLabel":"Standard practice", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Group receive the standard practice, without telephone nursing intervention." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Telenursing", "InterventionDescription":"The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Telenursing" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Satisfaction", "PrimaryOutcomeDescription":"Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview", "PrimaryOutcomeTimeFrame":"2 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Telenursing service utilisation", "SecondaryOutcomeDescription":"Telenursing service utilisation will be recorded in terms of number, time and duration of calls, who made the call, the nature of the call, decision made, description of the plan for action, and follow-through of the advice.", "SecondaryOutcomeTimeFrame":"2 years" },{ "SecondaryOutcomeMeasure":"Adherence to therapeutic regimen", "SecondaryOutcomeDescription":"Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)", "SecondaryOutcomeTimeFrame":"2 years" },{ "SecondaryOutcomeMeasure":"Cost effectiveness", "SecondaryOutcomeDescription":"Cost will be descriptive in nature and be estimated by calculating the cost related to the time for the use of the service by a qualified nurse versus what the parents would have done if the service was not avalaible.", "SecondaryOutcomeTimeFrame":"2 years" },{ "SecondaryOutcomeMeasure":"Clinical status (disease activity, QOL)", "SecondaryOutcomeDescription":"Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)", "SecondaryOutcomeTimeFrame":"2 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nChildren under the age of 17 years at the time of enrolment into the study\nNewly diagnosed (within 24 months from the enrolment date) with inflammatory rheumatologic diseases\nRegistered as outpatient in the clinic of paediatric rheumatology\nA parent (the mother or the father or the guardian) on behalf of their children.\n\nExclusion Criteria:\n\nChildren and parents who do not understand and speak French\nNo access to a telephone line.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"1 Year", "MaximumAge":"17 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Anne-Sylvie Ramelet, PhD", "OverallOfficialAffiliation":"Institut universitaire de formation et de recherche en soins-IUFRS", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University Hospital of Vaud - Department of Pediatrics", "LocationCity":"Lausanne", "LocationState":"Vaud", "LocationZip":"1011", "LocationCountry":"Switzerland" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28716081", "ReferenceType":"derived", "ReferenceCitation":"Ramelet AS, Fonjallaz B, Rio L, Zoni S, Ballabeni P, Rapin J, Gueniat C, Hofer M. Impact of a nurse led telephone intervention on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized clinical trial. BMC Pediatr. 2017 Jul 17;17(1):168. doi: 10.1186/s12887-017-0926-5." },{ "ReferencePMID":"24939642", "ReferenceType":"derived", "ReferenceCitation":"Ramelet AS, Fonjallaz B, Rapin J, Gueniat C, Hofer M. Impact of a telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized trial study protocol. BMC Pediatr. 2014 Jun 18;14:151. doi: 10.1186/1471-2431-14-151." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Swiss National Science Foundation", "SeeAlsoLinkURL":"http://p3.snf.ch/project-132135" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012213", "ConditionMeshTerm":"Rheumatic Fever" },{ "ConditionMeshId":"D000012216", "ConditionMeshTerm":"Rheumatic Diseases" },{ "ConditionMeshId":"D000003095", "ConditionMeshTerm":"Collagen Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000003240", "ConditionAncestorTerm":"Connective Tissue Diseases" },{ "ConditionAncestorId":"D000013290", "ConditionAncestorTerm":"Streptococcal Infections" },{ "ConditionAncestorId":"D000016908", "ConditionAncestorTerm":"Gram-Positive Bacterial Infections" },{ "ConditionAncestorId":"D000001424", "ConditionAncestorTerm":"Bacterial Infections" },{ "ConditionAncestorId":"D000001168", "ConditionAncestorTerm":"Arthritis" },{ "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13625", "ConditionBrowseLeafName":"Rheumatic Fever", "ConditionBrowseLeafAsFound":"Inflammatory Rheumatism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafAsFound":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafAsFound":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4730", "ConditionBrowseLeafName":"Chronic Disease", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7047", "ConditionBrowseLeafName":"Fever", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5047", "ConditionBrowseLeafName":"Connective Tissue Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14663", "ConditionBrowseLeafName":"Streptococcal Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3303", "ConditionBrowseLeafName":"Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17835", "ConditionBrowseLeafName":"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3057", "ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5025", "ConditionBrowseLeafName":"Rheumatic Fever", "ConditionBrowseLeafAsFound":"Inflammatory Rheumatism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T162", "ConditionBrowseLeafName":"Acute Articular Rheumatism", "ConditionBrowseLeafAsFound":"Inflammatory Rheumatism", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }