Nctid:
NCT06613204
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001037", "term"=>"Aphasia"}, {"id"=>"D057180", "term"=>"Frontotemporal Dementia"}, {"id"=>"D018888", "term"=>"Aphasia, Primary Progressive"}, {"id"=>"D020774", "term"=>"Pick Disease of the Brain"}, {"id"=>"D000088282", "term"=>"Corticobasal Degeneration"}, {"id"=>"D000084802", "term"=>"Caregiver Burden"}], "ancestors"=>[{"id"=>"D003704", "term"=>"Dementia"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D013064", "term"=>"Speech Disorders"}, {"id"=>"D007806", "term"=>"Language Disorders"}, {"id"=>"D003147", "term"=>"Communication Disorders"}, {"id"=>"D019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D013315", "term"=>"Stress, Psychological"}, {"id"=>"D001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D057174", "term"=>"Frontotemporal Lobar Degeneration"}, {"id"=>"D057177", "term"=>"TDP-43 Proteinopathies"}, {"id"=>"D019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D057165", "term"=>"Proteostasis Deficiencies"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D024801", "term"=>"Tauopathies"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M6904", "name"=>"Dementia", "relevance"=>"LOW"}, {"id"=>"M4352", "name"=>"Aphasia", "asFound"=>"Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"M20929", "name"=>"Aphasia, Primary Progressive", "asFound"=>"Primary Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"M22530", "name"=>"Pick Disease of the Brain", "asFound"=>"Primary Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"M28762", "name"=>"Frontotemporal Dementia", "asFound"=>"Frontotemporal Dementia", "relevance"=>"HIGH"}, {"id"=>"M2480", "name"=>"Caregiver Burden", "asFound"=>"Caregiver Burden", "relevance"=>"HIGH"}, {"id"=>"M2649", "name"=>"Corticobasal Degeneration", "asFound"=>"Corticobasal Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M15864", "name"=>"Speech Disorders", "relevance"=>"LOW"}, {"id"=>"M10823", "name"=>"Language Disorders", "relevance"=>"LOW"}, {"id"=>"M6374", "name"=>"Communication Disorders", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M16105", "name"=>"Stress, Psychological", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M28756", "name"=>"Frontotemporal Lobar Degeneration", "relevance"=>"LOW"}, {"id"=>"M28759", "name"=>"TDP-43 Proteinopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M28747", "name"=>"Proteostasis Deficiencies", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M23002", "name"=>"Tauopathies", "relevance"=>"LOW"}, {"id"=>"T4710", "name"=>"Primary Progressive Aphasia", "asFound"=>"Primary Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"T2399", "name"=>"Frontotemporal Dementia", "asFound"=>"Frontotemporal Dementia", "relevance"=>"HIGH"}, {"id"=>"T2400", "name"=>"Frontotemporal Dementia, Ubiquitin-positive", "asFound"=>"Primary Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"T5168", "name"=>"Semantic Dementia", "asFound"=>"Primary Progressive Aphasia", "relevance"=>"HIGH"}, {"id"=>"T1606", "name"=>"Corticobasal Degeneration", "asFound"=>"Corticobasal Syndrome", "relevance"=>"HIGH"}, {"id"=>"T704", "name"=>"Behavioral Variant of Frontotemporal Dementia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2023-10-20", "size"=>774232, "label"=>"Study Protocol and Statistical Analysis Plan", "hasIcf"=>false, "hasSap"=>true, "filename"=>"Prot_SAP_000.pdf", "typeAbbrev"=>"Prot_SAP", "uploadDate"=>"2024-09-19T15:52", "hasProtocol"=>true}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Interventionists will not be blinded, but will only teach their designated group (test or control)."}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"STELLA-FTD is a 36-week randomized controlled, repeated measures study."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>640}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2029-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-17", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Revised Memory and Behavior Problems Checklist, Frequency, Original Scale", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention", "description"=>"Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 96"}, {"measure"=>"Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention", "description"=>"Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on reactivity indicate more Care Partner burden. Frequency range is 0 (no burden) to 4 (high burden). Frequency score range is 0 to 96"}], "secondaryOutcomes"=>[{"measure"=>"Self-efficacy for symptom management and support service use", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention", "description"=>"10-item scale to measure self-efficacy. Assesses caregiver certainty that they will use services and support programing. 1= not at all certain, to 10=very certain. Scores range from 10 to 100, with 100 being high certainty."}, {"measure"=>"Neuropsychiatric Inventory-Caregiver Self-efficacy Scale", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention", "description"=>"Measures frequency of behaviors related to frontotemporal dementia and Care Partner confidence in managing behaviors. Frequency is rated on a scale of 1 (occasionally) to 4 (very frequently), severity is rated from 1 (mild) to 3 (severe), and caregiver distress is rated from 0 (no distress) to 5 (extreme or very severe). Total scores are calculated by multiplication of the frequency and severity for each symptom and the addition of all item scores, with a range of 0-144. The distress score total is calculated by the sum of all the individual domain scores, with a range of between 0 and 60. If a behavioral symptom is noted, the care partner is asked to about how confident they are in addressing it, Responses range from 4 (not at all confident), 3 (fairly confident), 2 (confident), and 1 (very confident)."}, {"measure"=>"Preparedness for Caregiving Scale", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention", "description"=>"10-item measure that assesses how prepared care partners feel to care for their family member with dementia. Ranges from 0 (not at all prepared) to 40 (very well prepared)."}, {"measure"=>"Personalized Target Behavior Survey", "timeFrame"=>"1 week pre-intervention, 8 week post intervention", "description"=>"On STELLA-FTD Website, measures frequency and reactivity of up to 3 personalized behaviors identified by Care Partners. Care partners rate how often the 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 4 for each Target behavior. Higher scores indicate higher frequency and burden."}, {"measure"=>"Service and Support use survey", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention", "description"=>"10-item survey that queries participants about service use. Score is not on a scale."}, {"measure"=>"Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey", "timeFrame"=>"1 week post intervention", "description"=>"18-item- survey on satisfaction, privacy, ease of use. Scores range from 1 (strongly disagree) to 5 (strongly agree). Total score ranged 18-90, higher scores are better"}, {"measure"=>"Orbit Survey", "timeFrame"=>"Weekly, starts at Week 1, ends after week 36.", "description"=>"Weekly survey of burden, service use, medication use. Score is not on a scale."}, {"measure"=>"Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention", "description"=>"Measures frequency of upsetting frontotemporal behaviors. 9 items, scores range from 0 (no behaviors) to 36 (all behaviors)"}, {"measure"=>"Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity", "timeFrame"=>"1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention", "description"=>"Measures caregivers reactions to upsetting frontotemporal behaviors. 9 items, scores range from 0 (no reactivity) to 36 (high reactivity)"}, {"measure"=>"Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration", "timeFrame"=>"One time assessment at enrollment", "description"=>"This is an 8-item survey that assesses disease severity, with 0=no impairment to 3=severe impairment. Range is 0-24 (Sum of boxes)"}, {"measure"=>"Ten Item Personality Inventory", "timeFrame"=>"Once, at Week 1 of intervention", "description"=>"10 items that assess personality type. Respondents note how they agree with each. personality type, from\n\n1=Disagree strongly 2 = Disagree moderately 3 = Disagree a little 4 = Neither agree nor disagree 5 = Agree a little 6 = Agree moderately 7 = Agree strongly\n\nScore is not on a scale."}, {"measure"=>"Contact Survey", "timeFrame"=>"Week 13, 20, and 36", "description"=>"Nine questions query caregivers about if they contacted other caregivers in the study, and, if so, how often. Score is not on a scale"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["behavioral intervention", "FTD"], "conditions"=>["Frontotemporal Dementia", "Caregiver Burden", "Primary Progressive Aphasia(PPA)", "Corticobasal Syndrome"]}, "referencesModule"=>{"availIpds"=>[{"url"=>"http://www.ohsu.edu/alzheimers-disease-research-center/data-resources", "type"=>"data set"}], "references"=>[{"pmid"=>"37655616", "type"=>"BACKGROUND", "citation"=>"Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent video-conference based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the US.", "detailedDescription"=>"The study will enroll a total sample of up to 640 participants: 320 family care partners and their 320 care Recipients with FTD. For our study \"family Care Partner\" includes any person who is considered \"family\" to the person with FTD, such as direct relations, fictive kin, close friends and neighbors. \"Care Recipient\" is defined as an individual with an FTD diagnosis noted by the AFTD: bv-FTD, PPA, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), or ALS with FTD. Care Recipients with FTD will not participate in intervention but will be consented (and thus enrolled) because data will collected about them. The study will test to see if our program helps Care Partners.\n\nThe STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour \"live\" video-based group sessions led by two guides. There will be two intervention groups, the control group and the test group. There will be up to 8 care Partners per group, which allows for the development of mutual trust and commitment.\n\nCare Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Both groups will receive information and support (via videoconferencing). The test group will receive a different program than the control group. Care Partners will fill out 6 long surveys while in the study, and a weekly brief survey."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria: Family Care Partner\n\n* Adult caring for family member with FTD.\n* Provides 4 or more hours of care/week. Does not have to reside with.\n* Identifies at least 2 moderately upsetting behaviors in the person with FTD.\n* Speaks and understands English to be able to participate in intervention.\n* Owns a telephone (smartphone, cell phone or landline).\n* Has email and mailing address to receive computer, study materials and surveys.\n* Provides informed consent to participate in the research.\n* Lives in the US\n\nInclusion Criteria: Person with FTD\n\n* Diagnosis of FTD\n* Family member of a Care Partner (this can be a relative, spouse, or close kin that is considered family).\n* Lives in US\n\nExclusion Criteria: Person with FTD\n\n* No Frontotemporal Degeneration diagnosis.\n* Unable to leave Care Partner during STELLA-FTD sessions.\n* Enrolled in hospice.\n\nExclusion Criteria: Family Care Partner\n\n* Unable to find activity for Care Recipient during STELLA-FTD sessions to allow Care Partner to work privately with Guide and other Care Partners.\n* Hearing and/or vision problems severe enough to prevent participation.\n* Refuses to be video-recorded during STELLA-FTD sessions.\n* Unwilling or unable to adequately follow study instructions and participate in study procedures."}, "identificationModule"=>{"nctId"=>"NCT06613204", "acronym"=>"STELLA-FTD", "briefTitle"=>"STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners", "organization"=>{"class"=>"OTHER", "fullName"=>"Oregon Health and Science University"}, "officialTitle"=>"STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners", "orgStudyIdInfo"=>{"id"=>"STUDY00026023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Control Group", "description"=>"Control group, receives information and support in a group setting (n=160 Care Partners)", "interventionNames"=>["Behavioral: STELLA-FTD Control"]}, {"type"=>"EXPERIMENTAL", "label"=>"Test Group", "description"=>"Test group, receives information and support in a group setting, but program is different from control (N=160 Care Partners)", "interventionNames"=>["Behavioral: STELLA-FTD Test"]}, {"type"=>"NO_INTERVENTION", "label"=>"Care Recipients with FTD", "description"=>"Care recipients are consented to inform them of their rights, but they do not take part in any activities."}], "interventions"=>[{"name"=>"STELLA-FTD Control", "type"=>"BEHAVIORAL", "description"=>"Participants receive information about FTD and support via weekly group video-conference-based meetings.", "armGroupLabels"=>["Control Group"]}, {"name"=>"STELLA-FTD Test", "type"=>"BEHAVIORAL", "description"=>"The test group receives a information and support, but with a focus that is different from the Control Group", "armGroupLabels"=>["Test Group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Christina Zonker", "role"=>"CONTACT", "email"=>"zonkerc@ohsu.edu", "phone"=>"503-816-8310"}, {"name"=>"Allison Lindauer, PhD, APRN", "role"=>"CONTACT", "email"=>"lindauer@ohsu.edu", "phone"=>"5034946976"}], "overallOfficials"=>[{"name"=>"Allison Lindauer, PhD, APRN", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Oregon Health & Science University"}, {"name"=>"Aimee Mooney, MA, CCC-SLP", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Oregon Health & Science University"}]}, "ipdSharingStatementModule"=>{"url"=>"https://www.ohsu.edu/alzheimers-disease-research-center/data-resources", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "ANALYTIC_CODE"], "timeFrame"=>"2/15/2025-7/14/2029", "ipdSharing"=>"YES", "description"=>"Aggregated data for journal articles and presentations, IPD via data request to OHSU", "accessCriteria"=>"Scientists can contact our center to request data"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Oregon Health and Science University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Allison Lindauer", "investigatorAffiliation"=>"Oregon Health and Science University"}}}}
