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Completed

NCT Number: NCT06557863

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

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.

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Key information

Conditions

Caregiver Burden Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Deglutition Disorders Dementia Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Oropharyngeal Dysphagia Otorhinolaryngologic Diseases Pharyngeal Diseases Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Care Partner Burden at 3 Months Post Hospital Discharge

    Time frame: 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.

Secondary outcomes

  1. Mean Care Partner Burden at 1 Month Post Hospital Discharge

    Time frame: 1 Month 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.

  2. Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge

    Time frame: 1 Month Post Hospital Discharge

    Care Partner Quality of Life (CarerQol) will be measured using the validated Care-Related Qol-7D. The Care-Related Qol-7D measures well-being (CarerQol-VAS or visual analog scale) and subjective burden. The CarerQol-VAS measures happiness, using endpoints between 'completely unhappy' (0) and 'completely happy' (10). Subjective burden is measured on 7 dimensions (fulfillment, relational problems, mental health, daily activities problems, physical health, and support), and rated as (i) no, (ii) some, and (iii) a lot. The weighted score ranges from 0-100 (worst to best caregiving situation). Higher scores indicate higher quality of life. 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.

  3. Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge

    Time frame: 3 Months Post Hospital Discharge

    Care Partner Quality of Life (CarerQol) will be measured using the validated Care-Related Qol-7D. The Care-Related Qol-7D measures well-being (CarerQol-VAS or visual analog scale) and subjective burden. The CarerQol-VAS measures happiness, using endpoints between 'completely unhappy' (0) and 'completely happy' (10). Subjective burden is measured on 7 dimensions (fulfillment, relational problems, mental health, daily activities problems, physical health, and support), and rated as (i) no, (ii) some, and (iii) a lot. The weighted score ranges from 0-100 (worst to best caregiving situation). Higher scores indicate higher quality of life. 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.

  4. Percent Engagement With the WeCareToFeedDysphagia Tool

    Time frame: 3 Months Post Hospital Discharge

    Engagement with WeCareToFeedDysphagia will be defined as percent of care partners viewing 2 or more pages within the tool. Success will be defined as greater than or equal to 45% of care partners engaging with the tool. Data will be captured via Google Analytics data to assess program usage in the domains of time/date of login, duration of page views, and document downloaded Engagement with the tool will be reported for the intervention arm only.

  5. Percent Consented in Pilot Study

    Time frame: Study completion, up to 1 year

    Percent consented will be calculated as care partners consented over eligible and approached. Success will be defined as greater than or equal to 40% of care partners approached will volunteer to enroll in the study.

  6. Percent Care Partner Attrition at 1 Month Post Hospital Discharge

    Time frame: 1 Month Post Hospital Discharge.

    Percent attrition will be calculated as the total number of consented participants who did not complete the 1 month assessment over the total number of consented participants. Success will be defined as less than or equal to 30% attrition at 1 month post hospital discharge.

  7. Percent Care Partner Attrition at 3 Months Post Hospital Discharge

    Time frame: 3 Months Post Hospital Discharge.

    Percent attrition will be calculated as the total number of consented participants who did not complete the 3 month assessment over the total number of consented participants. Success will be defined as less than or equal to 30% attrition at 3 months post hospital discharge.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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