Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R61AG079930 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Control + WeCareToFeedDysphagia | Experimental | 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 | No Intervention | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Care Partner Burden at 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. | 3 months post hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Care Partner Burden at 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liron Sinvani, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institutes for Medical Research | Manhasset | New York | 11030 | United States |
All data which can be sufficiently deidentified to preserve participant confidentiality will be made available via the Open Science Framework (OSF) repository. The goal of all shared data will be to facilitate replication of all primary and secondary, and exploratory study analyses as well as to allow for additional analyses with available data. Data will be redacted according to the safe-harbor method, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented (e.g. presenting an age category ">85 years old" rather than individual participant age). Information about how summary data was generated will be provided in the data dictionary.
Study data and metadata will be available in advance of the first online publication of the primary study outcomes. De-identified data will be stored on OSF indefinitely to allow for continued access.
Data will be made publicly available
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Enhanced Control | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
74 participants were actively enrolled at baseline. 6 participants were lost to follow-up prior to baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 8 participants missing age data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Care Partner Burden at 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. | 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. | Posted | Mean | Standard Deviation | ZBI Score | 1 Month Post Hospital Discharge |
|
Data for each participant was collected over a 3 month study participation period
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Liron Sinvani, Principal Investigator | Northwell Health | 516-562-2945 | ldanay@northwell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2024 | Apr 10, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 Month Post Hospital Discharge |
| Mean Care Partner Quality of Life at 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. | 1 Month Post Hospital Discharge |
| Mean Care Partner Quality of Life at 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. | 3 Months Post Hospital Discharge |
| Percent Engagement With the WeCareToFeedDysphagia Tool | 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. | 3 Months Post Hospital Discharge |
| Percent Consented in Pilot 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. | Study completion, up to 1 year |
| Percent Care Partner Attrition at 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. | 1 Month Post Hospital Discharge. |
| Percent Care Partner Attrition at 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. | 3 Months Post Hospital Discharge. |
| Enhanced Control |
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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. |
| OG001 | Enhanced Control | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
|
|
| Secondary | Mean Care Partner Quality of Life at 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. | 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. | Posted | Mean | Standard Deviation | CareQol Score | 1 Month Post Hospital Discharge |
|
|
|
| Secondary | Mean Care Partner Quality of Life at 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. | 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. | Posted | Mean | Standard Deviation | CareQol Score | 3 Months Post Hospital Discharge |
|
|
|
| Secondary | Percent Engagement With the WeCareToFeedDysphagia Tool | 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. | Posted | Count of Participants | Participants | 3 Months Post Hospital Discharge |
|
|
|
| Secondary | Percent Consented in Pilot 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. | 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. | Posted | Count of Participants | Participants | Study completion, up to 1 year |
|
|
|
| Secondary | Percent Care Partner Attrition at 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. | Posted | Count of Participants | Participants | 1 Month Post Hospital Discharge. |
|
|
|
| Secondary | Percent Care Partner Attrition at 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. | Posted | Count of Participants | Participants | 3 Months Post Hospital Discharge. |
|
|
|
| Primary | Mean Care Partner Burden at 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. | 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. | Posted | Mean | Standard Deviation | ZBI Score | 3 months post hospital discharge |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Enhanced Control | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Missing |
|
| Unknown or Not Reported |
|
| Asian |
|
| More than one race |
|
| Other |
|
| Unknown or Not Reported |
|