[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07250113":3,"trial-entities:NCT07250113":90,"trial-summary:NCT07250113":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":55,"minimum_age":56,"maximum_age":16,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":70,"locations":73,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT07250113","25-0388","WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT","ENROLLING_BY_INVITATION","2028-04","2026-07","2026-07-09","2026-02-17","Northwell Health","OTHER",true,"The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD\u002FADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are:\n\n* How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners?\n* Does the WeCareToFeed Dysphagia tool help improve patient outcomes?\n* Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool?\n* Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)?\n\nResearchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care).\n\nParticipants will:\n\n* be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only).\n* be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.",null,[18,19,20,21,22],"Caregiver Burden","Alzheimer's Disease","Dementia","Oropharyngeal Dysphagia","Older Adults",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},802,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","WeCareToFeedDysphagia web tool","The web tool uses written and video content, care-partner testimonials, frequently asked questions, and resource links to provide accurate information (e.g., dysphagia diets), set realistic expectations, identify\u002Fsupport feeding goals (quality of life considerations), acknowledge\u002Fsupport care-partner feelings, and provide competencies\u002Fskills for oropharyngeal dysphagia (OD) management.",[37],"Enhanced Control + WeCareToFeedDysphagia",[39],{"measure":40,"description":41,"timeFrame":42},"Mean Care Partner Burden at 3 Months Post Hospital Discharge","Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone\u002Fdevice via text message.","3 months from hospital discharge",[44,47,50,52],{"measure":45,"description":41,"timeFrame":46},"Mean Care Partner Burden at 1 Month Post Hospital Discharge","1 month from hospital discharge",{"measure":48,"description":49,"timeFrame":46},"Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge","Care Partner Quality of Life (CarerQol) will be measured using the validated Care-Related Qol-7D. The Care-Related Qol-7D measures well-being (CarerQol-VAS or visual analog scale) and subjective burden. The CarerQol-VAS measures happiness, using endpoints between 'completely unhappy' (0) and 'completely happy' (10). Subjective burden is measured on 7 dimensions (fulfillment, relational problems, mental health, daily activities problems, physical health, and support), and rated as (i) no, (ii) some, and (iii) a lot. The weighted score ranges from 0-100 (worst to best caregiving situation). Higher scores indicate higher quality of life. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone\u002Fdevice via text message.",{"measure":51,"description":49,"timeFrame":42},"Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge",{"measure":53,"description":54,"timeFrame":42},"Percent Engagement with the WeCareToFeedDysphagia Tool","Engagement with WeCareToFeedDysphagia will be defined as percent of care partners viewing 2 or more pages within the tool. Success will be defined as greater than or equal to 45% of care partners engaging with the tool. Data will be captured via Google Analytics data to assess program usage in the domains of time\u002Fdate of login, duration of page views, and document downloaded Engagement with the tool will be reported for the intervention arm only.","ALL","18 Years",false,{"inclusion":59,"exclusion":65,"raw_text":69},[60,61,62,63,64],"Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD\u002FADRD and oropharyngeal dysphagia (OD) admitted to the Northwell medicine service","Age ≥ 18 years","Designated as the legally authorized representative (LAR) or health care proxy (HCP), or designated by the LAR or HCP to participate","Proficient in English","Has access to a device (e.g. smartphone, iPad, computer) capable of accessing a web browser",[66,67,68],"Care partner of patient with a percutaneous feeding tube (i.e. PEG, PEJ used exclusively)","Care partner of patient who will not be discharged to the home or community setting (e.g., home, assisted living, independent living)","Care partner will not be involved with OD management (e.g. buying or making food, feeding, supervising) after hospital discharge","Inclusion Criteria:\n\n* Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD\u002FADRD and oropharyngeal dysphagia (OD) admitted to the Northwell medicine service\n* Age ≥ 18 years\n* Designated as the legally authorized representative (LAR) or health care proxy (HCP), or designated by the LAR or HCP to participate\n* Proficient in English\n* Has access to a device (e.g. smartphone, iPad, computer) capable of accessing a web browser\n\nExclusion Criteria:\n\n* Care partner of patient with a percutaneous feeding tube (i.e. PEG, PEJ used exclusively)\n* Care partner of patient who will not be discharged to the home or community setting (e.g., home, assisted living, independent living)\n* Care partner will not be involved with OD management (e.g. buying or making food, feeding, supervising) after hospital discharge",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"The Feinstein Institutes for Medical Research","Manhasset","New York","11030","United States",{"lat":81,"lon":82},40.79788,-73.69957,[],[85],{"name":86,"affiliation":12,"role":87},"Liron Sinvani, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":92},[19,20,21],[],{"nct_id":4,"found":57,"summary":16,"prompt_version":16}]