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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG079930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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 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:
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| 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. |
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| 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 greater 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 from 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 greater 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CARES Part A at 1 Month Post Hospital Discharge | The Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Part A Checklist of Behavioral Changes is a 10-item questionnaire that measures responses to yes/no statements. Part A is scored 1 point for every yes response out of a maximum of 10 points. Scores are continuous, with lower scores indicating more self-efficacy with behavioral management. 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liron Sinvani, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 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.
Deidentified data will be made publicly available.
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| 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 |
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| 1 month from 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 from 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 from 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 from hospital discharge |
| 1 month from hospital discharge |
| Mean CARES Part A at 3 Months Post Hospital Discharge | The Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Part A Checklist of Behavioral Changes is a 10-item questionnaire that measures responses to yes/no statements. Part A is scored 1 point for every yes response out of a maximum of 10 points. Scores are continuous, with lower scores indicating more self-efficacy with behavioral management. 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 from hospital discharge |
| Mean CARES Part B at 1 Month Post Discharge | The Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Part B Measures of Subjective Caregiver Stress is a 16-item questionnaire that measures responses to yes/no statements. Part B is scored 1 point for every yes response out of a maximum of 16 points. Scores are continuous, with lower scores indicating more self-efficacy with stress management. 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 from hospital discharge |
| Mean CARES Part B at 3 Months Post Hospital Discharge | The Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Part B Measures of Subjective Caregiver Stress is a 16-item questionnaire that measures responses to yes/no statements. Part B is scored 1 point for every yes response out of a maximum of 16 points. Scores are continuous, with lower scores indicating more self-efficacy with stress management. 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 from hospital discharge |
| Mean EdFED-Q at 1 Month Post Hospital Discharge | The Edinburgh Feeding Evaluation in Dementia Questionnaire (EdFED-Q) is an 11-item instrument which assesses eating and feeding problems in people with late-stage dementia. The care partner assigns a score (0 to 2, never, sometimes, or often occurring) to each item; higher scores (maximum of 20) indicate greater feeding dysfunction. 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 from hospital discharge |
| Mean EdFED-Q at 3 Months Post Hospital Discharge | The Edinburgh Feeding Evaluation in Dementia Questionnaire (EdFED-Q) is an 11-item instrument which assesses eating and feeding problems in people with late-stage dementia. The care partner assigns a score (0 to 2, never, sometimes, or often occurring) to each item; higher scores (maximum of 20) indicate greater feeding dysfunction. 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 from hospital discharge |
| Mean QUALID at 1 Month Post Hospital Discharge | The Quality of Life in Late-Stage Dementia Scale (QUALID) is an 11 item, validated scale administered to care partners for rating quality of life in late stage dementia. A 5 point scale (1-5) is used to capture the frequency of each item. Scores range from 11 to 55, with lower scores reflecting a 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 from hospital discharge |
| Mean QUALID at 3 Months Post Hospital Discharge | The Quality of Life in Late-Stage Dementia Scale (QUALID) is an 11 item, validated scale administered to care partners for rating quality of life in late stage dementia. A 5 point scale (1-5) is used to capture the frequency of each item. Scores range from 11 to 55, with lower scores reflecting a 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 from hospital discharge |
| Mean Patient Acute Care Visits at 1 Month Post Hospital Discharge | Care partners will be asked to report acute care visits defined as emergency department visits and hospital readmissions for the patient they care for. Visits will be distinguished as aspiration-related or non-aspiration related complaints and reported as yes (took place) or no (did not take place). More frequently reported acute care visits will be associated with worse patient outcomes. 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 from hospital discharge |
| Mean Patient Acute Care Visits at 3 Months Post Hospital Discharge | Care partners will be asked to report acute care visits defined as emergency department visits and hospital readmissions for the patient they care for. Visits will be distinguished as aspiration-related or non-aspiration related complaints and reported as yes (took place) or no (did not take place). More frequently reported acute care visits will be associated with worse patient outcomes. 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 from hospital discharge |
| Mean Patient Dehydration Events at 1 Month Post Hospital Discharge | Care partners will be asked to report dehydration events requiring intravenous or subcutaneous fluid administration for the patient they care for as yes (took place) or no (did not take place). More dehydration events will be associated with worse outcomes. 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 from hospital discharge |
| Mean Patient Dehydration Events 3 Months Post Hospital Discharge | Care partners will be asked to report dehydration events requiring intravenous or subcutaneous fluid administration for the patient they care for as yes (took place) or no (did not take place). More dehydration events will be associated with worse outcomes. 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 from hospital discharge |
| Mean Patient Weight Loss 1 Month Post Hospital Discharge | Caregivers will be asked to report patient weight loss via a single-item question derived from the Mini Nutritional Assessment (MNA). Results will be averaged and categorized as weight loss greater than 3 kg, weight loss 1-3 kg, and no weight loss. More weight loss will be associated with worse outcomes. 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 from hospital discharge |
| Mean Patient Weight Loss 3 Months Post Hospital Discharge | Caregivers will be asked to report patient weight loss via a single-item question derived from the Mini Nutritional Assessment (MNA). Results will be averaged and categorized as weight loss greater than 3 kg, weight loss 1-3 kg, and no weight loss. More weight loss will be associated with worse outcomes. 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 from hospital discharge |
| Mean NPI-Q 1 Month Post Hospital Discharge | The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. 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 from hospital discharge |
| Mean NPI-Q 3 Months Post Hospital Discharge | The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. 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 from hospital discharge |
| 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 |