Clinical trial NCT06557863: Reducing Burden in Care Partners of Community-Dwelling Persons With Dementia and Oropharyngeal Dysphagia
Official title: Reducing Burden in Care Partners of Community-Dwelling Persons With Dementia and Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver Burden
Alzheimer Disease
Dementia
Oropharyngeal Dysphagia
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change from Baseline in Mean Care Partner Burden at 3 Months Post Hospital Discharge
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from Baseline in Mean Care Partner Burden at 1 Month Post Hospital Discharge
timeFrame: Baseline and 1 Month Post Hospital Discharge
measure: Change from Baseline in Care Partner Quality of Life at 1 Month Post Hospital Discharge
timeFrame: Baseline and 1 Month Post Hospital Discharge
measure: Change from Baseline in Care Partner Quality of Life at 3 Months Post Hospital Discharge
timeFrame: Baseline and 3 Months Post Hospital Discharge
measure: Percent Engagement with the WeCareToFeedDysphagia Tool
timeFrame: 3 Months Post Hospital Discharge
measure: Percent Consented in Pilot Study
timeFrame: Study completion, up to 1 year
measure: Percent Care Partner Attrition at 1 Month Post Hospital Discharge
timeFrame: 1 Month Post Hospital Discharge.
measure: Percent Care Partner Attrition at 3 Months Post Hospital Discharge
timeFrame: 3 Months Post Hospital Discharge.
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institutes for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Liron Sinvani, MD
role: PRINCIPAL_INVESTIGATOR
References: