[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658994":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":42,"armGroups":47,"interventions":60,"overallOfficials":42,"centralContacts":70,"locations":80,"responsibleParty":98,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":42,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":42,"enrollmentInfo":115,"targetDuration":42,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":134,"whyStopped":42,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Northwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Zarit Caregiver Burden Score","The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire (Zarit, Reever \\& Bach-Peterson, 1980). The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The total score range is 0 to 88. Increasing scores indicate increasing burden.\n\nScores were measured at baseline and at 1 month post-intervention and a change score was computed for each participant. These change scores are averaged to produce the by-condition mean change in burden score. Positive results indicate an increase in burden, and negative results indicate a decrease in burden.","1 month post-intervention",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Change in DUTCH Conflict Handling Scores","The Dutch Test for Conflict Handling measures aspects of conflict resolution pertaining to the negotiator. The DUTCH measures conflict handling in five domains: avoiding, forcing, yielding, problem solving, and compromising. Each domain is measured independently using panels of four 1-5 likert scale questions each. Domain scores thus range from 5-20, converted to 0-100 with the following formula: 6.25\\*(domain score-1). Intra-participant change is measured for each subdomain between baseline and 1 month and generalized to produce mean change per domain. Higher scores per domain indicate more intense conflict handling behavior in the given domain- lower scores indicate less intensity.",{"measure":18,"description":19,"timeFrame":12},"Change in PROMIS Anxiety T-Score","The PROMIS Adult Emotional Distress-Anxiety scale measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness) in respondents during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). We deployed the four item short form, with scores ranging from 4-20, with higher scores indicating greater severity of anxiety. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.",{"measure":21,"description":22,"timeFrame":12},"Change in NIH Toolbox Adult Perceived Stress T-Score","The NIH Toolbox Adult Percieved Stress scale measures self-reported stress experienced by the subject in the past month. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=fairly often; and 5=very often). We deployed the ten item fixed form for adults (18+). Raw scores ranging from 10-50, with higher scores indicating greater perception of stress. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.",{"measure":24,"description":25,"timeFrame":12},"Change in PROMIS Fatigue T-Score","The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. We deployed PROMIS Fatigue Form 7a, a seven item likert scale panel ranging from 1=never to 5=always. Scores range from 7-35. Higher scores indicate more fatigue. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.",{"measure":27,"description":28,"timeFrame":12},"Change in PROMIS General Self Efficacy T-Score","the PROMIS General Self-Efficacy - Short Form is a four item panel which measures confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The four items are 1-5 Likert scales, 1=never, 5=always. Minimum score is a 4 and maximum is a 20. Raw Scores are converted to T scores with mean 50 and SD 10 per the PROMIS scoring manual. Higher score=greater self efficacy.",{"measure":30,"description":31,"timeFrame":12},"Change in Neuro-QoL Positive Affect and Well-being T-Score","Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect\u002Fwell-being, and negative change represents a decrease.",[33,36],{"measure":34,"description":35,"timeFrame":12},"Change in Negotiation Knowledge scores","We deployed a panel of 15 questions measuring participant knowledge of negotiation techniques. The panel measures knowledge in three subdomains (identification of interests, rights, and power statements) and can also be measured in aggregate to assess knowledge across the three subdomains. Participants receive 1 point for each correct answer. All Scores, including subdomain scores, are converted to a 0\u002F100 measure. Intraparticipant change is assessed between baseline and 1 month post-intervention. Dependent Sample T-Tests were performed on the change scores from baseline-1 month.",{"measure":37,"description":38,"timeFrame":12},"Change in Positive and Negative Affect Schedule Scores","The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores are evaluated out of 50. The ten item scales thus have score ranges from 10-50. Higher scores in a single domain indicate greater perception of that type of affect. So, higher positive affect scores=greater positive affect, and higher negative affect scores=higher negative affect. Positive change on either scale indicates an increase in that domain, and negative change on either scale indicates a decrease in that domain.",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":45,"maskingDescription":42,"whoMasked":42},"NONE","Family caregivers of persons living with Alzheimer's disease and related dementias (ADRD) frequently encounter communication challenges and interpersonal conflicts while coordinating care, making healthcare decisions, advocating for care recipients, and interacting with family members and healthcare professionals. These challenges contribute to caregiver burden, stress, anxiety, and reduced quality of life. Effective communication and conflict-management skills may improve caregivers' ability to navigate complex caregiving situations and support better caregiver outcomes.\n\nNegotiAge is a web-based negotiation and conflict-resolution training intervention developed to improve communication, problem-solving, and conflict-management skills among family caregivers of persons living with ADRD. The intervention includes online educational content and interactive scenario-based exercises that allow participants to practice negotiation and communication strategies in simulated caregiving situations. Scenarios address common caregiving conflicts involving persons living with dementia, family members, healthcare providers, and healthcare systems. Some training activities incorporate automated conversational technology to provide standardized practice opportunities.\n\nThis study is a Stage 2 randomized controlled efficacy trial designed to evaluate the effectiveness of NegotiAge. Approximately 200 family caregivers will be randomized in a 1:1 ratio to either the NegotiAge intervention or an attention-control condition consisting of access to an educational website. Participants will complete assessments at baseline, immediately following intervention completion, and at 1-month and 3-month follow-up.\n\nThe primary objective is to determine the efficacy of NegotiAge for reducing caregiver burden. Secondary objectives are to evaluate intervention effects on caregiver conflict-management behaviors, stress, anxiety, fatigue, self-efficacy, social well-being, and related psychosocial outcomes. Findings from this study will provide evidence regarding the efficacy of NegotiAge and inform future effectiveness and implementation research aimed at supporting family caregivers of persons living with Alzheimer's disease and related dementias.\n\nThis is a fully remote study. Eligible participants may enroll from anywhere within the United States.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"NegotiAge Intervention","EXPERIMENTAL","Participants assigned to this arm will receive access to NegotiAge, a self-paced, web-based negotiation and conflict-resolution training program for family caregivers of persons living with Alzheimer's disease and related dementias. The intervention includes educational modules and interactive scenario-based practice exercises designed to improve communication, negotiation, problem-solving, and conflict-management skills. Participants complete the intervention online using a computer, tablet, or smartphone.",[53],"Behavioral: NegotiAge",{"label":55,"type":56,"description":57,"interventionNames":58},"PlanYourLifespan Attention-Control","ACTIVE_COMPARATOR","Participants assigned to this arm will receive access to PlanYourLifespan (PYL), a web-based educational resource that provides information and planning tools related to future healthcare needs, caregiving, hospitalizations, memory loss, communication with family members, and financial planning. Participants may review website content during the study period.",[59],"Behavioral: PlanYourLifespan",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":42},"BEHAVIORAL","NegotiAge","NegotiAge is a self-paced, web-based negotiation and conflict-resolution training program designed for family caregivers of persons living with Alzheimer's disease and related dementias. The intervention consists of educational modules and interactive scenario-based practice exercises that teach communication, negotiation, problem-solving, and conflict-management skills. Training content addresses common caregiving situations, including communication with persons living with dementia, disagreements among family members, healthcare decision-making, and interactions with healthcare providers and health systems. Participants access the intervention through a secure online platform and complete the training independently using a computer, tablet, or smartphone. Some practice exercises utilize automated conversational technology to provide standardized opportunities to practice negotiation and communication skills in simulated caregiving scenarios.",[49],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":42},"PlanYourLifespan","PlanYourLifespan (PYL) is a web-based educational planning resource that provides information and tools related to future healthcare needs, caregiving, memory loss, family communication, hospitalizations, and financial planning.",[55],[71,76],{"name":72,"role":73,"phone":74,"phoneExt":42,"email":75},"Alaine Murawski","CONTACT","(312) 503-7981","negotiage@northwestern.edu",{"name":77,"role":73,"phone":78,"phoneExt":42,"email":79},"Vanessa Ramirez-Zohfeld","(312) 503-3916","vanessa-ramirez-0@northwestern.edu",[81],{"facility":82,"status":42,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-87.65005,41.85003,{"lat":92,"lon":91},[95],{"name":96,"role":97,"phone":42,"phoneExt":42,"email":42},"Lee A Lindquist, MD, MPH, MBA","PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Lee Lindquist","Professor",[102],{"name":103,"class":104},"National Institute on Aging (NIA)","NIH","100658994","negotiation-training-for-family-caregivers-of-people-with-alzheimers-disease-100658994",false,"NCT07859540","Negotiation Training for Family Caregivers of People With Alzheimer's Disease","Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease","Inclusion Criteria:\n\n* Age 21 years or older\n* Self-identify as a family caregiver or unpaid care partner of a person with Alzheimer's disease, a related dementia, cognitive impairment, or memory loss.\n* Provide at least 2 hours per week of assistance, support, advocacy, healthcare coordination, or decision-making for the care recipient.\n* Able to read, understand, and communicate in English.\n* Able and willing to provide informed consent.\n* Have regular access to an internet-connected computer, tablet, or smartphone and be comfortable using web-based programs and surveys.\n* Willing to be randomized to either the NegotiAge intervention group or the attention-control group and complete all study assessments.\n\nExclusion Criteria:\n\n* Prior participation in PlanYourLifespan studies (STU00209195 or STU00225351).\n* Prior participation in any NegotiAge study (STU00212921).\n* Younger than 21 years of age.\n* Not currently serving as a family caregiver or unpaid care partner for a person with Alzheimer's disease, a related dementia, cognitive impairment, or memory loss.\n* Unable to provide informed consent.\n* Unable to read, understand, or communicate in English sufficiently to complete study activities.\n* Significant cognitive impairment or another condition that would prevent meaningful participation in study activities.\n* Lack of access to the technology required for participation in the online intervention and study assessments.",true,"ALL","21 Years",{"count":116,"type":117},200,"ESTIMATED","INTERVENTIONAL",[120],"NA","Family caregivers of people living with Alzheimer's disease and related dementias often experience conflicts and communication challenges when coordinating care, making decisions, and interacting with family members and healthcare providers. These challenges can contribute to caregiver burden, stress, anxiety, and reduced well-being.\n\nThe purpose of this study is to evaluate the effectiveness of NegotiAge, an online negotiation and communication training program designed for family caregivers. NegotiAge provides education and interactive practice exercises to help caregivers develop negotiation, problem-solving, conflict-resolution, and communication skills that can be applied to real-world caregiving situations.\n\nApproximately 200 family caregivers will be randomly assigned to either the NegotiAge intervention or an attention-control educational website. Participants will complete online surveys before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up time-points. The study will examine whether NegotiAge reduces caregiver burden and improves communication, conflict-management behaviors, self-efficacy, stress, anxiety, fatigue, and well-being. Findings from this research may help improve support programs for family caregivers of people living with Alzheimer's disease and related dementias.",[123,124,125],"Alzheimer's Disease (AD)","Dementia","Cognitive Impairment",[127,124,128,129,130,131,132,133],"Alzheimer's Disease","Family caregiver","Caregiver burden","Negotiation training","Caregiver communication","Behavioral intervention","Online intervention","NOT_YET_RECRUITING","2026-09-29",{"date":137,"type":138},"2026-10-05","ACTUAL",{"date":140,"type":117},"2026-11",{"date":142,"type":117},"2028-08-31",{"name":5,"class":6},1]