Reducing Burden in Care Partners of Community-Dwelling Persons With Dementia and Oropharyngeal Dysphagia

NCT ID: NCT06557863

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-08-01

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 first test (pilot) study aims to answer are:

• With the data this pilot study will collect, how do we best measure how strong a relationship is between care partners who use WeCareToFeedDysphagia and reduced feelings of burden (effect size estimates)?
• Is it possible (feasible) to successfully repeat this study in a larger clinical trial with more research participants?

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.

Conditions

Caregiver Burden; Alzheimer Disease; Dementia; Oropharyngeal Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

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

Inclusion Criteria

• Self identifies as the primary care partner of an older adult patient (patient aged 65 years or older) with Alzheimer's disease and related dementias (AD/ADRD) and oropharyngeal dysphagia (OD) admitted to the Northwell Health medicine service
• Care partner age 18 years or older
• 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. percutaneous endoscopic gastrostomy (PEG) tube, percutaneous endoscopic jejunostomy (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

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Liron Sinvani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liron Sinvani, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Feinstein Institutes for Medical Research

Manhasset, New York, United States

Countries

United States

Other Identifiers

R61AG079930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0196

Identifier Type: -

Identifier Source: org_study_id