Reducing Burden in Care Partners of Community-Dwelling Persons With Dementia and Oropharyngeal Dysphagia
- Conditions
- DementiaCaregiver BurdenOropharyngeal DysphagiaAlzheimer Disease
- Interventions
- Behavioral: WeCareToFeedDysphagia web tool
- Registration Number
- NCT06557863
- Lead Sponsor
- Northwell Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Control + WeCareToFeedDysphagia WeCareToFeedDysphagia web tool 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Mean Care Partner Burden at 3 Months Post Hospital Discharge Baseline and 3 months 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.
- Secondary Outcome Measures
Name Time Method Percent Care Partner Attrition at 1 Month Post Hospital Discharge 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.
Change from Baseline in Mean Care Partner Burden at 1 Month Post Hospital Discharge Baseline and 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. Change will be calculated as the mean value at 1 month minus the mean value at baseline.
Percent Consented in Pilot Study 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.
Percent Care Partner Attrition at 3 Months Post Hospital Discharge 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.
Change from Baseline in Care Partner Quality of Life at 1 Month Post Hospital Discharge Baseline and 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. Change will be calculated as the mean value at 1 month minus the mean value at baseline.
Change from Baseline in Care Partner Quality of Life at 3 Months Post Hospital Discharge Baseline and 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. Change will be calculated as the mean value at 3 months minus the mean value at baseline.
Percent Engagement with the WeCareToFeedDysphagia Tool 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.
Trial Locations
- Locations (1)
Feinstein Institutes for Medical Research
🇺🇸Manhasset, New York, United States