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

NCT06557863 | Completed DMC

• 2 other identifiers: 24-0196R61AG079930
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 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 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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in 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 less 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. Change will be calculated as the mean value at 3 months minus the mean value at baseline.

  Baseline and 3 months

Secondary Outcomes (7)

• Change from Baseline in Mean Care Partner Burden at 1 Month Post Hospital Discharge

  Baseline and 1 Month Post Hospital Discharge

• Change from Baseline in Care Partner Quality of Life at 1 Month Post Hospital Discharge

  Baseline and 1 Month Post Hospital Discharge

• Change from Baseline in Care Partner Quality of Life at 3 Months Post Hospital Discharge

  Baseline and 3 Months Post Hospital Discharge

• Percent Engagement with the WeCareToFeedDysphagia Tool

  3 Months Post Hospital Discharge

• Percent Consented in Pilot Study

  Study completion, up to 1 year

Study Arms (2)

Enhanced Control + WeCareToFeedDysphagia

EXPERIMENTAL

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.

Behavioral: WeCareToFeedDysphagia web tool

Enhanced Control

NO INTERVENTION

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

Interventions

WeCareToFeedDysphagia web tool 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 + WeCareToFeedDysphagia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Alzheimer Disease; Dementia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Liron Sinvani, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

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: August 14, 2024
• First Posted: August 16, 2024
• Study Start: October 8, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

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: Data will be made publicly available

Locations

US (1)