WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT

Обзор

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/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are: * How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners? * Does the WeCareToFeed Dysphagia tool help improve patient outcomes? * Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool? * 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)? Researchers 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). Participants will: * be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only). * 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.

Вмешательства

• Поведенческое 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/support feeding goals (quality of life considerations), acknowledge/support care-partner feelings, and provide competencies/skills for oropharyngeal dysphagia (OD) management.

Первичные конечные точки

• Mean Care Partner Burden at 3 Months Post Hospital Discharge [Срок оценки: 3 months from hospital discharge]

Вторичные конечные точки (4)

• Mean Care Partner Burden at 1 Month Post Hospital Discharge [Срок оценки: 1 month from hospital discharge]
• Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge [Срок оценки: 1 month from hospital discharge]
• Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge [Срок оценки: 3 months from hospital discharge]
• Percent Engagement with the WeCareToFeedDysphagia Tool [Срок оценки: 3 months from hospital discharge]

Критерии участия

Критерии включения

• Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD/ADRD 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The Feinstein Institutes for Medical Research — Manhasset

Идентификаторы

NCT: NCT07250113 · 25-0388 · R33AG079930

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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