Nctid:
NCT06225986
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003704", "term"=>"Dementia"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M6904", "name"=>"Dementia", "asFound"=>"Dementia", "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"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>140}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-08", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-25", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Grief Severity as measured by the Prolonged Grief-12-Revised (PG-12-R)", "timeFrame"=>"Baseline, 2 Weeks, 4 Weeks", "description"=>"Caregivers' pre-loss grief assessed using the validated 12-item PG-12-R instrument; Scores ranging from 12-60, with higher scores indicative of greater feelings of pre-loss grief."}, {"measure"=>"Change in Relationship Quality as measured by the Relationship Quality Scale", "timeFrame"=>"Baseline, 2 Weeks, 4 Weeks", "description"=>"Relationship quality will be assessed using the validated Relationship Quality Scale (RSQ). Total scores range from 5-30. Higher scores reflect better relationship quality."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Dyadic Family Caregiver-person With Dementia Online Intervention"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories.\n\nThe main aims of this study are:\n\n* To evaluate the feasibility and acceptability of the LMH-4-DCP platform.\n* To explore the potential for LMH-4-DCP to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('Care-Pairs')\n\nCare pair participants will be asked to log-in to LMH-4-DCP and complete study activities three times per week for one month. Researchers will compare the intervention group to an attention control condition to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.", "detailedDescription"=>"The goal of this randomized controlled trial is to evaluate the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) web application, a dyadic online psychosocial reminiscence platform, to reduce feelings of pre-loss grief and improve relationship quality in individuals with dementia and their family caregivers ('Care Pairs').\n\nThe main aims of this study are:\n\n* To evaluate the feasibility and acceptability of the LMH-4-DCP platform.\n* To explore the influence of the LMH-4-DCP intervention on reducing feelings of pre-loss grief and enhancing relationship quality in the care pair\n\nCare pair participants randomized to the intervention condition will be asked to log-iin to LMH-4-DCP and complete reminiscence activities three times per week for one month. Researchers will compare the intervention group to an attention control condition, which includes LMH-4-DCP use without reminiscence-specific features, to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nFamily Caregivers:\n\n* be a primary source of care for a family member in the early to moderate stages of dementia\n* 18 years of age or older\n* English-speaking\n* does not exhibit cognitive impairment (e.g., scoring \\< 3 on the SPMSQ)\n* able to use the internet and has internet access.\n\nPwD\n\n* if the caregiver deems the PwD able\n* the PwD scores \\< 8 on the Short Portable Mental Status Questionnaire (SPMSQ)\n* demonstrates capacity to consent to a low-risk study as indicated by a score of ≥9 on the University of California-San Diego Brief Assessment of Capacity to Consent.\n\nExclusion Criteria:\n\nFamily Caregivers:\n\n* is not the primary family caregiver of the PwD\n* under the age of 18-years-old\n* exhibits cognitive impairment (by scoring 3 or more on the SPMSQ)\n* does not speak English as a primary language.\n\nPwD:\n\n* severe cognitive impairment detected by the clinical or study staff using validated, brief screening tools (e.g., a score of 8 errors or more on the SPMSQ)\n* does not demonstrate capacity to consent (e.g., a score of 9 or fewer errors on the University of California-San Diego Brief Assessment of Capacity to consent\n* PwD is living in a long-term care facility\n* does not speak English as a primary language\n* is under the age of 18 years-old."}, "identificationModule"=>{"nctId"=>"NCT06225986", "acronym"=>"LMH-4-DCP", "briefTitle"=>"Living Memory Home-4-Dementia Care Pairs", "organization"=>{"class"=>"OTHER", "fullName"=>"Weill Medical College of Cornell University"}, "officialTitle"=>"The Living Memory Home: Reducing Grief and Improving Relationships Between Home-Based Patients With ADRD and Their Family Caregivers", "orgStudyIdInfo"=>{"id"=>"23-07026251"}, "secondaryIdInfos"=>[{"id"=>"R21AG077144", "link"=>"https://reporter.nih.gov/quickSearch/R21AG077144", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"LMH-4-DCP Intervention", "interventionNames"=>["Behavioral: LMH-4-DCP"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Attention Control Arm", "interventionNames"=>["Behavioral: LMH-4-DCP access without reminiscence activities"]}], "interventions"=>[{"name"=>"LMH-4-DCP", "type"=>"BEHAVIORAL", "description"=>"Reminiscence-based intervention for family caregiver-Persons with Dementia (PwD) dyads to record and reflect on meaningful memories to address family caregivers' pre-loss grief and enhance relationship quality.", "armGroupLabels"=>["LMH-4-DCP Intervention"]}, {"name"=>"LMH-4-DCP access without reminiscence activities", "type"=>"BEHAVIORAL", "description"=>"Participants in the attention control condition will have access to a version of LMH-4-DCP excluding reminiscence-specific activities.", "armGroupLabels"=>["Attention Control Arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "contacts"=>[{"name"=>"Sosi E Korian, B.S", "role"=>"CONTACT", "email"=>"sek4011@med.cornell.edu", "phone"=>"201-249-1265"}, {"name"=>"Holly G Prigerson, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Weill Cornell Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "centralContacts"=>[{"name"=>"Sosi E Korian", "role"=>"CONTACT", "email"=>"sek4011@med.cornell.edu", "phone"=>"646-962-5637"}], "overallOfficials"=>[{"name"=>"Holly Prigerson, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Weill Medical College of Cornell University"}, {"name"=>"Francesca Falzarano, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Southern California; Weill Cornell Medicine"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "ANALYTIC_CODE"], "timeFrame"=>"These data will be shared after we have published the specific aims of this study. Requests for the code used to create LMH-4-Dementia Care Pairs will be reviewed by the investigative team and shared once we have published the findings showing it is safe and therapeutic.", "ipdSharing"=>"YES", "description"=>"Data collected for the LMH-4-Dementia Care Pairs study will only be shared after we have published the data addressing the study's specific aims. Intellectual property and data generated under this project will be administered in accordance with both Weill Cornell Medicine (WCM) and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. After publication of our main findings, access to databases and associated software tools generated and the code to create these tools under the project will be available for educational, research and non-profit purposes.", "accessCriteria"=>"1) to use the data for research purposes only; 2) not to identify any individual participant; 3) to secure the data using appropriate computer technology such as password-protected servers and files; and 4) to return and/or destroy data after analyses are complete."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Weill Medical College of Cornell University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Aging (NIA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
