WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT
2 other identifiers
interventional
802
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
November 26, 2025
CompletedStudy Start
First participant enrolled
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 16, 2026
March 1, 2026
1.9 years
November 18, 2025
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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/device via text message.
3 months from hospital discharge
Secondary Outcomes (4)
Mean Care Partner Burden at 1 Month Post Hospital Discharge
1 month from hospital discharge
Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge
1 month from hospital discharge
Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge
3 months from hospital discharge
Percent Engagement with the WeCareToFeedDysphagia Tool
3 months from hospital discharge
Other Outcomes (16)
Mean CARES Part A at 1 Month Post Hospital Discharge
1 month from hospital discharge
Mean CARES Part A at 3 Months Post Hospital Discharge
3 months from hospital discharge
Mean CARES Part B at 1 Month Post Discharge
1 month from hospital discharge
- +13 more other outcomes
Study Arms (2)
Enhanced Control + WeCareToFeedDysphagia
EXPERIMENTALParticipants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. Participants will also receive access to the WeCareToFeedDysphagia web tool and receive text message reminders to use the tool.
Enhanced Control
NO INTERVENTIONParticipants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- National Institute on Aging (NIA)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liron Sinvani, MD
Northwell Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 18, 2025
First Posted
November 26, 2025
Study Start
February 17, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study data and metadata will be available in advance of the first online publication of the primary study outcomes. De-identified data will be stored on OSF indefinitely to allow for continued access.
- Access Criteria
- Deidentified data will be made publicly available.
All data which can be sufficiently deidentified to preserve participant confidentiality will be made available via the Open Science Framework (OSF) repository. The goal of all shared data will be to facilitate replication of all primary and secondary, and exploratory study analyses as well as to allow for additional analyses with available data. Data will be redacted according to the safe-harbor method, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented (e.g. presenting an age category "\>85 years old" rather than individual participant age). Information about how summary data was generated will be provided in the data dictionary.