Northwell Health, in collaboration with the National Institute on Aging (NIA) and the National Institutes of Health (NIH), is moving forward with a groundbreaking full-scale randomized clinical trial (RCT) called “WeCareToFeedDysphagia to Reduce Care-partner Burden.” Announced on November 26, 2025, this trial investigates the use of the WeCareToFeedDysphagia web tool aimed at reducing caregiver burden related to managing oropharyngeal dysphagia in individuals with Alzheimer’s disease, dementia, and other conditions affecting older adults. Recruitment for this trial has not yet begun.
What changed?
The latest update clarifies that this innovative trial will soon proceed but is not recruiting participants yet. This clinical study seeks to introduce new methods for alleviating the challenges faced by caregivers managing the nutritional needs of older individuals with dysphagia. Such developments are pivotal as clinical practices increasingly focus on empowering caregivers through evidence-based digital tools.
What are the trial’s objectives?
The primary objective is to evaluate the effectiveness of the WeCareToFeedDysphagia web tool, a behavioral intervention, in reducing caregiver burden. The intervention incorporates scientifically backed strategies for managing feeding and related complications in older adults with swallowing difficulties, particularly those with Alzheimer’s disease and dementia. By integrating behavioral modules, the web tool offers tailored support to educate and assist caregivers in managing complex nutritional requirements with greater ease.
This full-scale RCT is a critical continuation of earlier-stage trials aimed at validating the tool’s efficacy, safety, and user acceptance. Northwell Health, a leading healthcare provider, plays a central role alongside the NIA and the NIH, further cementing the collaboration’s scientific rigor.
Study implications
If successful, this intervention has the potential to decrease the emotional and physical toll on caregivers while delivering a higher standard of care for patients struggling with oropharyngeal dysphagia. This aligns with broader policy objectives regarding aging populations and improving home healthcare strategies. Additionally, using digital tools presents an opportunity to reduce healthcare costs by facilitating independent caregiver roles.
Why is this relevant?
Dysphagia, or difficulty swallowing, is a debilitating condition that significantly affects older adults, particularly those with cognitive impairments like dementia or Alzheimer’s disease. Caregivers often face the dual challenge of managing feeding processes and preventing secondary complications such as malnutrition, dehydration, or aspiration pneumonia.
The burden extends beyond physical tasks, leading to mental health strains, frustration, and burnout. With advancements in behavioral health-driven technologies, tools like WeCareToFeedDysphagia expand caregivers’ access to practical, well-researched solutions. Stakeholders in healthcare innovation, including clinical quality teams and policymakers, will likely benefit from tracking the outcomes of this trial closely.
Regulatory and clinical context
Ensuring the safety and intended performance of medical interventions, particularly digital behavioral tools, requires stringent clinical RCTs. This trial underlines a growing recognition by federal institutions like the NIH of the layered impacts of caregiving in the context of aging-related conditions. Evaluating solutions grounded in real-world usability and compliance with clinical standards boosts innovation legitimacy while fostering regulatory advancements.
FAQs
1. Who is conducting the trial?
Northwell Health, in collaboration with the NIA and NIH, sponsors the study.
2. What conditions does the intervention target?
The tool addresses caregiver burdens associated with Alzheimer’s disease, dementia, and oropharyngeal dysphagia, particularly in older adults.
3. What is dysphagia?
Dysphagia refers to a swallowing disorder that affects the ability to move food or liquids from the mouth to the stomach.
4. When does participant recruitment begin?
Recruitment has not started as of the publication date.
Conclusion
This upcoming RCT represents a significant step in exploring innovative caregiving solutions. Findings may impact how healthcare professionals, regulators, and caregivers approach comprehensive management for dysphagia and related conditions. Stakeholders should monitor recruitment announcements and future results for actionable insights.
Disclaimer
This article is informational and tailored for healthcare, clinical, and regulatory professionals. It does not constitute legal or clinical guidance. Consult official trial sources for detailed study protocols.
Announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250113?term=medical+device