Web Tool for Caregiver Burden in Alzheimer's Disease

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Feeding tube, Not discharged home, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new website tool called WeCareToFeedDysphagia. The researchers aim to determine if this tool can reduce stress for caregivers of loved ones with Alzheimer's and swallowing difficulties. Caregivers will either use the tool or not, allowing for a comparison of results. The trial seeks primary caregivers of Alzheimer's patients with swallowing issues who will continue their care after hospital discharge. As an unphased trial, it offers caregivers the chance to contribute to innovative solutions that may ease their caregiving journey.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on using a web tool to help caregivers, so it's unlikely that your medications will be affected.

What prior data suggests that the WeCareToFeedDysphagia web tool is safe for use by caregivers?

Research shows that WeCareToFeedDysphagia aims to reduce the stress experienced by caregivers of people with Alzheimer's disease. This tool is a website, requiring no medication or physical treatment, thus eliminating the risk of physical side effects.

Previous studies on similar caregiver support tools have not reported harmful effects, as they primarily offer information and guidance. The main goal is to ease caregivers' lives and reduce stress. As an online tool, it is generally considered safe to use. Participants in the study will also have access to a speech-language pathologist for additional support. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the WeCareToFeedDysphagia web tool because it offers a fresh approach to managing caregiver burden in Alzheimer's patients with dysphagia, a swallowing disorder. Unlike traditional treatments that rely solely on speech-language pathology and medical team support, this tool provides caregivers with easy access to resources and reminders through a user-friendly digital platform. This innovative method not only supports caregivers directly but also enhances their ability to provide effective care, potentially leading to better outcomes for Alzheimer's patients.

What evidence suggests that the WeCareToFeedDysphagia web tool is effective for reducing caregiver burden in Alzheimer's disease?

Research shows that caring for someone with Alzheimer's disease can be challenging, particularly during mealtimes, which can increase the difficulty for caregivers. Early studies suggest that certain methods can ease this burden. In this trial, participants in one arm will receive access to the WeCareToFeedDysphagia tool, designed to assist caregivers with feeding, along with text message reminders to use the tool. While specific data on the tool's effectiveness is not yet available, it is based on evidence that structured support can reduce caregiver stress. The upcoming trials will evaluate how effectively this tool eases the burden on caregivers. ^{5 6 7 8 9}

Who Is on the Research Team?

Liron Sinvani, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for primary care partners, aged 18 or older, of patients 65+ with Alzheimer's and related dementias who have swallowing difficulties. Participants must speak English, be the patient's legal representative or designated by them, and have web access.

Inclusion Criteria

I am proficient in English.

I am legally authorized to make decisions for a patient.

I have a device like a smartphone or computer that can access the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive access to the WeCareToFeedDysphagia tool and receive 3 text message reminders over 3 weeks to use the tool.

3 weeks

Remote, web-based survey at baseline, 1 month, and 3 months

Follow-up

Participants are monitored for changes in care partner burden and quality of life at 1 month and 3 months post hospital discharge.

3 months

Remote, web-based survey at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• WeCareToFeedDysphagia

Trial Overview The study tests if a website tool called WeCareToFeedDysphagia can ease the burden on caregivers of dementia patients with swallowing issues. It compares caregivers using this tool to those without it while both receive expert contact info.

How Is the Trial Designed?

Group I: Enhanced Control + WeCareToFeedDysphagia Experimental Treatment 1 Intervention

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 II: Enhanced Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06557863

Study Details | NCT06557863 | Reducing Burden in Care ... 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.

2. highergov.com highergov.com/grant/R33AG079930/

Grant R33AG079930 The Feinstein Institutes For Medical ... The R33 phase will determine the efficacy of WeCareToFeedDysphagia to reduce care-partner burden by: conducting a 24-month, full-scale RCT (N=406) at 11 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10392878/

Caregiver burden related to feeding process in Alzheimer's ... The so-called caregiver burden (CB) is a very frequent condition and can lead to a reduction in the caregiver's quality of life and a worsening of the patient's ...

4. demneuropsy.com.br demneuropsy.com.br/wp-content/uploads/articles_xml/1980-5764-DN-17-e20220092/1980-5764-DN-17-e20220092.pdf

Caregiver burden related to feeding process in Alzheimer's ... Objectives: Evaluate the relationship between the feeding process in individuals with AD and their caregiver's burden. Methods: Dyads of individuals with AD and.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11036232/

Interventions Effective in Decreasing Burden in Caregivers ... They are associated with older age groups, but data show that 15 million of all deaths attributed to NCDs occur between the ages of 30 and 69 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10082513/

Risk factors associated with home care safety for older people ... Family caregivers had a heavy caregiving burden, were less concerned about the safety of OPwD, and neglected to prevent adverse events in home ...

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1130099/full

How both positive and burdensome caregiver experiences ... Decades of evidence have shown that the stress and burden of caregiving is associated with poorer physical and mental health outcomes in ...

8. withpower.com withpower.com/clinical-trials/for-alzheimers-disease-near-new-york-ny?page=3

93 Alzheimer's Disease Trials near New York, NY Web Tool for Caregiver Burden in Alzheimer's Disease ... WeCareToFeedDysphagia ... The study will also determine the tolerability/safety outcomes of ECT+UC.

9. highergov.com highergov.com/awardee/northwell-health-inc-10010532/

Northwell Health Profile ... WeCareToFeedDysphagia for reducing burden in care partners of community-dwelling persons with Alzheimer's disease (AD) and... T2255331, HRSA Office of ...