[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657783":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":48,"studyPopulation":11,"armGroups":49,"interventions":61,"overallOfficials":70,"centralContacts":11,"locations":74,"responsibleParty":93,"collaborators":95,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":11,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":11,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":122,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of dyads who complete at least 4 out of 6 music\u002Fcontrol condition sessions",null,"Up to the end of treatment, 6 weeks",{"measure":14,"description":15,"timeFrame":12},"Percentage of dyads who rate the music\u002Fcontrol condition sessions after intervention as highly acceptable\u002Fsatisfactory (the average score is greater than 3)","Researchers will evaluate the acceptability of each condition using the Acceptability of Intervention Measure (AIM). The AIM has 4 statements on a 5-point Likert scale, on which responses range from 1=completely disagree to 5=completely agree.",[17,20,24,26,30,32,34,37],{"measure":18,"description":19,"timeFrame":12},"Reasons for dyad drop out","The reason why the dyad decided to drop out will be documented",{"measure":21,"description":22,"timeFrame":23},"Number of dyads screened per month","Recruitment will be assessed as number of dyads screened per month","Through study completion, an average of 1 year",{"measure":25,"description":11,"timeFrame":23},"Number of dyads enrolled per month",{"measure":27,"description":28,"timeFrame":29},"Percentage of eligible dyads who enroll","Enrollment success will be calculated as percent of eligible dyads who enroll","At enrollment",{"measure":31,"description":11,"timeFrame":29},"Percentage of dyads who enroll and agree to be randomized",{"measure":33,"description":11,"timeFrame":12},"Percentage of dyads who complete baseline and follow-up measures",{"measure":35,"description":36,"timeFrame":12},"Percentage of sessions delivered according to the protocol","The study team will audit 20% of cases for feedback and adherence checks using an already-developed fidelity checklist from prior work.",{"measure":38,"description":39,"timeFrame":12},"Percentage of measures that are completed at baseline and post intervention","Data collection burden will be reported as the percent of measures that are completed at baseline and post intervention.",{"allocation":41,"interventionModel":42,"interventionModelDescription":11,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":11,"whoMasked":46},"SINGLE",[47],"OUTCOMES_ASSESSOR","The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Persons Living With Dementia (PLWD) - Caregiver Dyads","EXPERIMENTAL","The interventionist will meet with the PLWD and their care partner via Zoom to identify and build a playlist of the PLWD's preferred music on a mobile device. The interventionist will use Gerdner's Assessment of Personal Music to learn about preferred genres, music artists, and types of music, and also review the PLWD's CDs, vinyl records, cassettes, and other music media to identify music.",[55],"Behavioral: Dyadic Music-based Intervention (MBI)",{"label":57,"type":58,"description":11,"interventionNames":59},"Reminiscence activity","PLACEBO_COMPARATOR",[60],"Behavioral: Reminiscence Activity",[62,66],{"type":63,"name":64,"description":48,"armGroupLabels":65,"otherNames":11},"BEHAVIORAL","Dyadic Music-based Intervention (MBI)",[51],{"type":63,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"Reminiscence Activity","The control condition intends to isolate the impact of music in the dyadic MBI and will consist of an object-based reminiscence activity shared by the dyad. The duration, dose, frequency, and timing in the control condition will match that of the intervention group.",[57],[71],{"name":72,"affiliation":5,"role":73},"Darina Petrovsky","PRINCIPAL_INVESTIGATOR",[75],{"facility":5,"status":11,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Durham","North Carolina","27710","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-78.89862,35.99403,{"lat":85,"lon":84},[88],{"name":89,"role":90,"phone":91,"phoneExt":11,"email":92},"Darina Petrovsky, PhD, RN","CONTACT","9196817041","PetrovskyResearch@duke.edu",{"type":94,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[96,99],{"name":97,"class":98},"National Institutes of Health (NIH)","NIH",{"name":100,"class":98},"National Center for Complementary and Integrative Health (NCCIH)","100657783","feasibility-of-a-dyadic-music-based-intervention-for-persons-living-with-dementia-and-their-care-partners-100657783",false,"NCT07843043","Feasibility of a Dyadic Music-based Intervention for Persons Living With Dementia and Their Care Partners","The Feasibility of a Dyadic Music-Based Intervention for Persons Living With Dementia and Their Care Partners","Inclusion for patient:\n\n1. Age 60 and older\n2. Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent.\n3. Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship (score of 3 or less on the relationship satisfaction measure), given that one member's dissatisfaction affects the other.\n4. Stable dose of psychotropic medications, sedatives\u002Fhypnotics, anti-dementia medications or opioids in the past 60 days to minimize the confounding effects of medications.\n\nExclusion for patient:\n\n1. Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1\u002F2 feet) to exclude those who cannot hear the music intervention.\n2. Planned transition to a residential or institutional care setting in less than 3 months (to decrease attrition).\n3. Currently enrolled in an interventional clinical trial for PLWD aimed to improve relationship quality (to not confound the results)\n4. Receiving hospice services.\n\nInclusion for care partner:\n\n1. Must reside with the patient.\n2. At least 21 years.\n3. Self-identify as the primary care partner\n4. Able to speak and read English\n5. If on psychotropic medications at the time of telephone screen must be on a stable dose of the medication for 60 days prior to enrollment.\n6. Consider themselves a family member (blood or non-blood relative)\n\nExclusion for care partner:\n\n1. Do not reside with patient\n2. Under the age of 21 years of age\n3. Is not primary care partner\n4. Not able to speak and read English\n5. Has not been on a stable dose of psychotropic medications for 60 days prior to enrollment.","ALL","21 Years",{"count":111,"type":112},60,"ESTIMATED","INTERVENTIONAL",[115],"NA","This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.",[118],"Dementia",[118,120,121],"Music therapy","Caregivers","NOT_YET_RECRUITING","2026-10-01",{"date":125,"type":126},"2026-10-05","ACTUAL",{"date":128,"type":112},"2027-08-01",{"date":130,"type":112},"2029-07-31",{"name":5,"class":6},1]