Nctid:
NCT06221254
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003424", "term"=>"Crohn Disease"}], "ancestors"=>[{"id"=>"D000015212", "term"=>"Inflammatory Bowel Diseases"}, {"id"=>"D000005759", "term"=>"Gastroenteritis"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}], "browseLeaves"=>[{"id"=>"M6638", "name"=>"Crohn Disease", "asFound"=>"Crohn's Disease", "relevance"=>"HIGH"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M17917", "name"=>"Inflammatory Bowel Diseases", "relevance"=>"LOW"}, {"id"=>"M8875", "name"=>"Gastroenteritis", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"200 CD patients divided into two equal groups: Intervention and control."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-08-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-14", "studyFirstSubmitDate"=>"2023-08-31", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Effectiveness of application as compared to human therapist.", "timeFrame"=>"12 months", "description"=>"Develop a smartphone application that will teach the patient COBMINDEX and to determine whether the application will be as effective as the psychological intervention delivered by the therapists.\n\nthe primary end point is SIBDQ disease specific HRQOL. 10 questions each scale 1-7 with range 7-70. higher is better."}], "secondaryOutcomes"=>[{"measure"=>"Cost-effectiveness", "timeFrame"=>"12 months", "description"=>"To determine the cost-effectiveness of the intervention as provided by application versus therapists by prospective monitoring of direct and indirect healthcare costs. A cost-effectiveness analysis to assess the value for money of the application versus therapist interventions will be performed using primary data collected from patients in the study. These data include information of utilization of healthcare services reported by patients. The cost of each service will be based on the Israel Ministry of Health List Price for health services. We will calculate indirect costs of lost productivity based on patient responses to the WPAI questionnaire. For each patient we will calculate the quality-adjusted life-year (QALY) based on responses to the SF-12 questionnaires"}, {"measure"=>"Effects of intervention on microbiome", "timeFrame"=>"12 months", "description"=>"alpha + beta diversity"}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nWPAI- Work Productivity and Activity Impairment. four types of scores:\n\n1. Absenteeism\n2. Presenteesism\n3. Work productivty loss\n4. Activity Impairment all presented in presentage 0-100. higher is worse."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nSWLS -The 5-item scale 0-7 \"satisfaction with life scale\" range 0-35 higher is better."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nFACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nBrief COPE- The Brief-COPE is a 28 item self-report questionnaire range 0-4 higher is worse."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\n. BSI- The Brief Symptom Inventory a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 =\"not at all\" to 4=\"extremely\")"}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nPSS-4, Perceived Stress Scale 4. 4-item 0-4 score. range 0-16 higher is worse."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nFMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better."}, {"measure"=>"Psychological improvment", "timeFrame"=>"12 months", "description"=>"Psychological self-report questionnaires\n\nSUDS- Subjective Units of Distress Scale. range 0-100 higher is worse."}, {"measure"=>"disease severity measurement", "timeFrame"=>"12 months", "description"=>"C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation."}, {"measure"=>"disease severity measurement", "timeFrame"=>"12 months", "description"=>"calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation."}, {"measure"=>"disease severity measurement", "timeFrame"=>"12 months", "description"=>"Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Crohn's Disease", "Health related quality of life", "Cognitive behavioral therapy", "Mindfulness", "Immune regulation", "Healthcare cost"], "conditions"=>["Crohn Disease"]}, "descriptionModule"=>{"briefSummary"=>"Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.", "detailedDescription"=>"200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application.\n\nIn the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment.\n\nIn the following 9-month period, all patients will practice using the application, each group by it's permissions.\n\nThere will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status.\n\nThroughout the trial, adverse events and concomitant medications will be collected."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Willingness to participate and signed informed consent\n* Hebrew-speaking\n* Age 18-75\n* Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis\n* Stable medical treatment for the last 3 months\n* Any Harvey Bradshaw Index score\n* Ability to operate a smartphone and cellular application\n\nExclusion Criteria:\n\n* Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease\n* Planned surgery for Crohn's disease\n* Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months\n* Psychiatric disease (schizophrenia, major depression or bipolar disorder)\n* Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)\n* Pregnancy or planned pregnancy during study period\n* Clinically significant comorbidity\n* Former participation in COBMINDEX trials"}, "identificationModule"=>{"nctId"=>"NCT06221254", "acronym"=>"COBMINDEX", "briefTitle"=>"A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Soroka University Medical Center"}, "officialTitle"=>"Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease", "orgStudyIdInfo"=>{"id"=>"SOR-0351-22-CTIL"}, "secondaryIdInfos"=>[{"id"=>"SCRC22051", "type"=>"OTHER", "domain"=>"Soroka Clinical Research Center"}, {"id"=>"MOH_2023-04-30_012589", "type"=>"REGISTRY", "domain"=>"Ministry of Health MyTrial"}, {"id"=>"2203-05901", "type"=>"OTHER_GRANT", "domain"=>"The Leona M. and Harry B. Helmsley Charitable Trust"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention- COBMINDEX application", "description"=>"The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise using a research dedicated application. Than, additional 9 months of practicing daily only with the application.", "interventionNames"=>["Behavioral: COBMINDEX digital application"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Control- COBMINDEX with Human therapist", "description"=>"The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise with human therapist, and than practicing daily only with the application.", "interventionNames"=>["Behavioral: Human therapist (Control)"]}], "interventions"=>[{"name"=>"COBMINDEX digital application", "type"=>"BEHAVIORAL", "description"=>"COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques and practices using digital application.", "armGroupLabels"=>["Intervention- COBMINDEX application"]}, {"name"=>"Human therapist (Control)", "type"=>"BEHAVIORAL", "description"=>"COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques from a human therapist (the comperator for learning from the application) and practices using digital application.", "armGroupLabels"=>["Control- COBMINDEX with Human therapist"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"8410101", "city"=>"Be'er Sheva", "status"=>"RECRUITING", "country"=>"Israel", "contacts"=>[{"name"=>"Doron Schwartz, MD", "role"=>"CONTACT", "email"=>"DoronSh@clalit.org.il", "phone"=>"+972523919044"}, {"name"=>"Shmuel Odes, MD", "role"=>"CONTACT", "email"=>"odes@bgu.ac.il", "phone"=>"+97252700752"}], "facility"=>"Soroka University Medical Center", "geoPoint"=>{"lat"=>31.25181, "lon"=>34.7913}}, {"zip"=>"3109601", "city"=>"Haifa", "status"=>"NOT_YET_RECRUITING", "country"=>"Israel", "contacts"=>[{"name"=>"Haggai Bar-Yoseph, MD", "role"=>"CONTACT", "email"=>"h_bar-yoseph@rambam.health.gov.il", "phone"=>"+972-4-7772850"}], "facility"=>"Rambam Health Care Campus i", "geoPoint"=>{"lat"=>32.81841, "lon"=>34.9885}}, {"zip"=>"4941492", "city"=>"Petah Tikva", "status"=>"NOT_YET_RECRUITING", "country"=>"Israel", "contacts"=>[{"name"=>"Henat Yanai, MD", "role"=>"CONTACT", "email"=>"henitya@clalit.org.il", "phone"=>"+972-3-9377040"}], "facility"=>"Belinson Medical Center", "geoPoint"=>{"lat"=>32.08707, "lon"=>34.88747}}, {"zip"=>"5266202", "city"=>"Ramat Gan", "status"=>"NOT_YET_RECRUITING", "country"=>"Israel", "contacts"=>[{"name"=>"Adi Lahat -Zok, Prof.", "role"=>"CONTACT", "email"=>"zokadi@gmail.com", "phone"=>"+972-3-302197"}], "facility"=>"Sheba Medical Center", "geoPoint"=>{"lat"=>32.08227, "lon"=>34.81065}}], "centralContacts"=>[{"name"=>"Doron Schwartz, MD", "role"=>"CONTACT", "email"=>"DoronSh@clalit.org.il", "phone"=>"+972-52-3919044"}, {"name"=>"Shmuel Odes, MD", "role"=>"CONTACT", "email"=>"odes@bgu.ac.il", "phone"=>"+972-52-2700752"}], "overallOfficials"=>[{"name"=>"Ruthie Bekore, MPH", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Soroka University Medical Center"}, {"name"=>"Ganit Goren, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Ben-Gurion University of the Negev"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Soroka University Medical Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"The Leona M. and Harry B. Helmsley Charitable Trust", "class"=>"OTHER"}, {"name"=>"Ben-Gurion University of the Negev", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Senior Physician, Department of Gastroenterology and Hepatology", "investigatorFullName"=>"Dr Doron Schwartz", "investigatorAffiliation"=>"Soroka University Medical Center"}}}}
