Nctid:
NCT06616857
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003550", "term"=>"Cystic Fibrosis"}, {"id"=>"D000005355", "term"=>"Fibrosis"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D000007232", "term"=>"Infant, Newborn, Diseases"}], "browseLeaves"=>[{"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M6755", "name"=>"Cystic Fibrosis", "asFound"=>"Cystic Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M10276", "name"=>"Infant, Newborn, Diseases", "relevance"=>"LOW"}, {"id"=>"T1710", "name"=>"Cystic Fibrosis", "asFound"=>"Cystic Fibrosis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Recruitment", "timeFrame"=>"Baseline", "description"=>"Recruitment: Our recruitment goal is 30 AYAs with CF."}, {"measure"=>"Retention", "timeFrame"=>"3-month", "description"=>"Retention: Our criterion for success is no more than 20% attrition."}, {"measure"=>"Engagement", "timeFrame"=>"3-month", "description"=>"Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE."}, {"measure"=>"Acceptability", "timeFrame"=>"3-month", "description"=>"Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews."}], "secondaryOutcomes"=>[{"measure"=>"Actigraphy", "timeFrame"=>"Baseline, 3-month, and 6-month", "description"=>"We will objectively measure AYA's moderate-to-vigorous PA for 7-days via ActiGraph wGT3X-BT accelerometers. All data will be processed using Actilife software. We will remove periods of non-wear and sleep; days with \\>10-hours of valid data during waking hours will be retained. Data will be binned into 15 second epochs and processed using the Chandler algorithm."}, {"measure"=>"Lung Functioning", "timeFrame"=>"Baseline, 3-month, and 6-month", "description"=>"Lung function will be assessed for 7-days via the AM1+ portable spirometer. AYAs will undergo a standardize training and complete three maximal effort blows every morning and evening. The main outcomes will be forced expiratory volume in one second (FEV1) percent predicted."}, {"measure"=>"CF Quality of Life", "timeFrame"=>"Baseline, 3-month, and 6-month", "description"=>"AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["physical activity"], "conditions"=>["Cystic Fibrosis (CF)"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity\n\nParticipants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:\n\n* Set and review goals\n* Self-monitor progress\n* Provide feedback on goal attainment\n* Revise future goals", "detailedDescription"=>"The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"25 years", "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. 13-25 years old\n2. Has a verified CF diagnosis or CF-related disorder\n3. Medically stable (i.e., FEV1\\>30%, not experiencing a CF-related exacerbation)\n4. Speaks and reads English\n\nExclusion Criteria:\n\n1. Have a comorbidity limiting PA participation (e.g., neurological condition)\n2. Have a significant cognitive impairment that interferes with study completion\n3. Have any oxygen, CPAP or BiPAP requirement"}, "identificationModule"=>{"nctId"=>"NCT06616857", "acronym"=>"NUDGE", "briefTitle"=>"Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis", "organization"=>{"class"=>"OTHER", "fullName"=>"Nemours Children's Clinic"}, "officialTitle"=>"Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis", "orgStudyIdInfo"=>{"id"=>"2158063"}, "secondaryIdInfos"=>[{"id"=>"003780A122", "type"=>"OTHER_GRANT", "domain"=>"Cystic Fibrosis Foundation"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"NUDGE", "interventionNames"=>["Behavioral: NUDGE"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Education", "interventionNames"=>["Other: Education"]}], "interventions"=>[{"name"=>"NUDGE", "type"=>"BEHAVIORAL", "description"=>"Individuals in this condition will receive intervention content to promote physical activity.", "armGroupLabels"=>["NUDGE"]}, {"name"=>"Education", "type"=>"OTHER", "description"=>"Individuals will receive educational materials about how to increase physical activity", "armGroupLabels"=>["Education"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"32207", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Nemours Childrens Health", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"Plans to share IPD will need to be discussed with the IRB."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Nemours Children's Clinic", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Cystic Fibrosis Foundation", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Research Scientist", "investigatorFullName"=>"David Fedele", "investigatorAffiliation"=>"Nemours Children's Clinic"}}}}
