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| ID | Type | Description | Link |
|---|---|---|---|
| K76AG059997-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (I-HoME) | Experimental | Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-HoME | Other | Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study | Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants. | Recruitment (7 months) |
| Feasibility, as Measured by the Percentage of Tele-visits Conducted | Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient. | At the end of the intervention or at 12 weeks, whichever is earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire | Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD. | Baseline, 2, 4, 6, 8, 10, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veerawat Phongtankuel, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (I-HoME) | Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (I-HoME) | Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study | Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants. | All participants who we reached out to and were eligible for our study, including those who refused to participate or were unreachable over multiple attempts, were included in the number of participants analyzed for this measure. | Posted | Number | percentage of all eligible participants | Recruitment (7 months) |
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12 weeks
Only caregivers of patients with ADRD, not their care recipients, were assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (I-HoME) | Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Veerawat Phongtankuel | Weill Cornell Medicine | 212-746-7000 | vep9012@med.cornell.edu |
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| 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 | Jun 26, 2024 | Aug 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2023 | Jun 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression. | Baseline, 2, 4, 6, 8, 10, 12 week |
| Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety. | Baseline, 2, 4, 6, 8, 10, 12 weeks |
| Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden. | Baseline, 2, 4, 6, 8, 10, 12 weeks |
| Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain. | Baseline, 2, 4, 6, 8, 10, 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Highest Education Completed | Count of Participants | Participants |
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| Annual Household Income Range | Count of Participants | Participants |
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| Relationship to Patient | Count of Participants | Participants |
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| Participants |
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| Primary | Feasibility, as Measured by the Percentage of Tele-visits Conducted | Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient. | Posted | Number | percentage of tele-visits conducted | At the end of the intervention or at 12 weeks, whichever is earlier | Tele-visits | Tele-visits |
|
|
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| Secondary | Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire | Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD. | This measure was not collected because, after completing the first phase of the study, we found it was not relevant to the participants in the clinical trial. | Posted | Baseline, 2, 4, 6, 8, 10, 12 weeks |
|
|
| Secondary | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression. | The number of participants analyzed at each time point varied because: A caregiver was ineligible to participate due to their care recipient passing away. A caregiver missed the tele-visit session on that particular week. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8, 10, 12 week |
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|
|
| Secondary | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety. | The number of participants analyzed at each time point varied because: A caregiver was ineligible to participate due to their care recipient passing away. A caregiver missed the tele-visit session on that particular week. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8, 10, 12 weeks |
|
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| Secondary | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden. | The number of participants analyzed at each time point varied because: A caregiver was ineligible to participate due to their care recipient passing away. A caregiver missed the tele-visit session on that particular week. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8, 10, 12 weeks |
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| Secondary | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain. | The number of participants analyzed at each time point varied because: A caregiver was ineligible to participate due to their care recipient passing away. A caregiver missed the tele-visit session on that particular week. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8, 10, 12 weeks |
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