WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT

NCT ID: NCT07250113

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Older Adults Caregiver Burden Alzheimer's Disease Dementia Oropharyngeal Dysphagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enhanced Control + WeCareToFeedDysphagia

Participants 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.

Group Type EXPERIMENTAL

WeCareToFeedDysphagia web tool

Intervention Type BEHAVIORAL

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.

Enhanced Control

Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liron Sinvani

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liron Sinvani, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordinator

Role: CONTACT

718-757-2758

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R33AG079930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-0388

Identifier Type: -

Identifier Source: org_study_id