Trial Outcomes & Findings for Reducing Burden in Care Partners of Community-Dwelling Persons With Dementia and Oropharyngeal Dysphagia (NCT NCT06557863)
NCT ID: NCT06557863
Last Updated: 2026-06-01
Results Overview
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.
COMPLETED
NA
80 participants
3 months post hospital discharge
2026-06-01
Participant Flow
Participant milestones
| Measure |
Enhanced Control + WeCareToFeedDysphagia
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.
|
Enhanced Control
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Baseline
|
36
|
38
|
|
Overall Study
1 Month Post Discharge
|
34
|
36
|
|
Overall Study
COMPLETED
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Enhanced Control + WeCareToFeedDysphagia
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.
|
Enhanced Control
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
8 participants missing age data.
Baseline characteristics by cohort
| Measure |
Enhanced Control + WeCareToFeedDysphagia
n=36 Participants
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.
|
Enhanced Control
n=38 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
3 Participants
n=36 Participants
|
7 Participants
n=38 Participants
|
10 Participants
n=74 Participants
|
|
Age, Continuous
|
55.8 Years
STANDARD_DEVIATION 11.6 • n=34 Participants • 8 participants missing age data.
|
53.6 Years
STANDARD_DEVIATION 9.8 • n=32 Participants • 8 participants missing age data.
|
54.7 Years
STANDARD_DEVIATION 10.8 • n=66 Participants • 8 participants missing age data.
|
|
Sex/Gender, Customized
Sex · Female
|
27 Participants
n=36 Participants
|
24 Participants
n=38 Participants
|
51 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
7 Participants
n=36 Participants
|
10 Participants
n=38 Participants
|
17 Participants
n=74 Participants
|
|
Sex/Gender, Customized
Sex · Missing
|
2 Participants
n=36 Participants
|
4 Participants
n=38 Participants
|
6 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=36 Participants
|
9 Participants
n=38 Participants
|
10 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=36 Participants
|
21 Participants
n=38 Participants
|
52 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=36 Participants
|
8 Participants
n=38 Participants
|
12 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
20 Participants
n=36 Participants
|
19 Participants
n=38 Participants
|
39 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
6 Participants
n=36 Participants
|
9 Participants
n=38 Participants
|
15 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=36 Participants
|
0 Participants
n=38 Participants
|
4 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=36 Participants
|
1 Participants
n=38 Participants
|
2 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=36 Participants
|
2 Participants
n=38 Participants
|
4 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: 3 months post hospital dischargePopulation: 65 participants were actively enrolled at 3 months post discharge. 11 participants were lost to baseline prior to 3 months. 4 participants were withdrawn prior to 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.
Outcome measures
| Measure |
Enhanced Control
n=34 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=31 Participants
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.
|
|---|---|---|
|
Mean Care Partner Burden at 3 Months Post Hospital Discharge
|
42.8 ZBI Score
Standard Deviation 17.2
|
41.3 ZBI Score
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 1 Month Post Hospital DischargePopulation: 70 participants were actively enrolled at 1 month post discharge. 7 participants were lost to follow up prior to 1 month. 3 participants were withdrawn prior to 1 month. Of the 70 actively enrolled participants, 4 are missing care partner burden data at 1 month post 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.
Outcome measures
| Measure |
Enhanced Control
n=33 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=33 Participants
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.
|
|---|---|---|
|
Mean Care Partner Burden at 1 Month Post Hospital Discharge
|
43.7 ZBI Score
Standard Deviation 14.5
|
41.7 ZBI Score
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 1 Month Post Hospital DischargePopulation: 70 participants were actively enrolled at 1 month post discharge. 7 participants were lost to follow up prior to 1 month. 3 participants were withdrawn prior to 1 month. Of the 70 actively enrolled participants, 5 are missing care partner quality of life data at 1 month post 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.
Outcome measures
| Measure |
Enhanced Control
n=33 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=32 Participants
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.
|
|---|---|---|
|
Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge
|
54.8 CareQol Score
Standard Deviation 13.7
|
53.9 CareQol Score
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 3 Months Post Hospital DischargePopulation: 65 participants were actively enrolled at 3 months post discharge. 11 participants were lost to baseline prior to 3 months. 4 participants were withdrawn prior to 3 months. Of the 65 actively enrolled participants, 2 are missing care partner quality of life data at 3 months post 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.
Outcome measures
| Measure |
Enhanced Control
n=32 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=31 Participants
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.
|
|---|---|---|
|
Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge
|
52.7 CareQol Score
Standard Deviation 16.7
|
57.7 CareQol Score
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 3 Months Post Hospital DischargeEngagement 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.
Outcome measures
| Measure |
Enhanced Control
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=40 Participants
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.
|
|---|---|---|
|
Percent Engagement With the WeCareToFeedDysphagia Tool
|
—
|
21 Participants
|
SECONDARY outcome
Timeframe: Study completion, up to 1 yearPopulation: A total of 164 participants were eligible and approached for consent. Of the 164 eligible participants, 80 (48.78%) participants officially consented and enrolled in the research study.
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.
Outcome measures
| Measure |
Enhanced Control
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=164 Participants
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.
|
|---|---|---|
|
Percent Consented in Pilot Study
Number of Participants Officially Consented
|
—
|
80 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Enhanced Control
n=40 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=40 Participants
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.
|
|---|---|---|
|
Percent Care Partner Attrition at 1 Month Post Hospital Discharge
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Enhanced Control
n=40 Participants
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
|
Enhanced Control + WeCareToFeedDysphagia
n=40 Participants
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.
|
|---|---|---|
|
Percent Care Partner Attrition at 3 Months Post Hospital Discharge
|
6 Participants
|
9 Participants
|
Adverse Events
Enhanced Control + WeCareToFeedDysphagia
Enhanced Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Liron Sinvani, Principal Investigator
Northwell Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place