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| ID | Type | Description | Link |
|---|---|---|---|
| 1K76AG059997-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Visiting Nurse Service of New York | OTHER |
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With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME).
The study intervention focuses on assessing and addressing patient symptoms in the home hospice setting through weekly telehealth visits (for up to 6 weeks) and educational videos that are geared for the patient's informal caregiver. The aim of this phase of the project is two fold. One is that the study team will conduct a single armed (N=6 dyads) pilot study with a focus on optimizing data collection protocols and the intervention. After this step, a randomized pilot study evaluating the feasibility and potential efficacy of I-HoME (N=50 dyads) compared to usual care (N=50 dyads) will be conducted.
Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Standard of care. | |
| I-HoME intervention | Experimental | Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-HoME | Behavioral | I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment Rate | Recruitment rate was measured by the number of participants consented divided by the number of eligible participants. | During recruitment (22 months) |
| Participant Attrition From Enrollment to End of Study | This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent. | At the end of the intervention or at 6 weeks, which ever is earlier. |
| Average Length of I-HoME Tele-visit | This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist. | At the end of the intervention or at 6 weeks, which ever is earlier. |
| Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants | This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist. | At the end of the intervention or at 6 weeks, which ever is earlier. |
| Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues. | At the end of the intervention or at 6 weeks, which ever is earlier. |
| Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Symptom burden score as measured by the Edmonton Symptom Assessment Scale (ESAS). Scale is from a 0 to 90, with higher scores indicating higher symptom burden. | At baseline and weekly for 6 weeks. |
| Number of Patient Hospitalizations From Enrollment to End of Intervention |
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Inclusion Criteria:
Home hospice caregivers must be:
Home hospice patients must be:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veerawat Phongtankuel, MD, MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Visiting Nurse Service of New York | New York | New York | 10017 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Standard of care. |
| FG001 | I-HoME Intervention | Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. I-HoME: I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Standard of care. |
| BG001 | I-HoME Intervention | Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. I-HoME: I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos. |
| 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 | Participant Recruitment Rate | Recruitment rate was measured by the number of participants consented divided by the number of eligible participants. | All participants who we reached out to and were eligible for our study, including those who refused to participate, were unreachable over multiple attempts, and those who were initially interested in participating but not enrolled were included in the number of participants analyzed for this measure. | Posted | Number | percentage of enrolled participants | During recruitment (22 months) |
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4 months
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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 | Control Arm | Standard of care. | 0 |
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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 | Sep 5, 2024 | Dec 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2024 | Dec 10, 2024 | ICF_001.pdf |
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After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period. |
| At the end of the intervention or at 6 weeks, which ever is earlier. |
| Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits. | This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits. | At the end of the intervention or at 6 weeks, which ever is earlier. |
All hospitalizations of the caregivers' patient from enrollment to end of intervention |
| From enrollment to the end of the intervention or at 6 weeks, which ever is earlier. |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
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| Highest Education Completed | Count of Participants | Participants |
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| Relationship to Patient | Count of Participants | Participants |
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| Annual Household Income Range | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
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| Primary | Participant Attrition From Enrollment to End of Study | This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent. | This measure includes all participants who were enrolled. | Posted | Count of Participants | Participants | At the end of the intervention or at 6 weeks, which ever is earlier. |
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| Primary | Average Length of I-HoME Tele-visit | This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist. | The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention. | Posted | Mean | Standard Deviation | minutes | At the end of the intervention or at 6 weeks, which ever is earlier. |
|
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|
| Primary | Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants | This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist. | The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention. | Posted | Number | videos | At the end of the intervention or at 6 weeks, which ever is earlier. |
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| Primary | Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues. | The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention. | Posted | Count of Participants | Participants | At the end of the intervention or at 6 weeks, which ever is earlier. |
|
|
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| Primary | Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits | After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period. | This measure was unable to be collected because it was difficult to distinguish hardware issues from other technical issues, which were reported in Primary Outcome #5. | Posted | At the end of the intervention or at 6 weeks, which ever is earlier. |
|
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| Primary | Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits. | This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits. | The total number of tele-visits completed by the I-HoME intervention arm participants was divided by the intended number of tele-visits for this group. The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention. | Posted | Number | percentage of tele-visits conducted out | At the end of the intervention or at 6 weeks, which ever is earlier. |
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| Secondary | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Symptom burden score as measured by the Edmonton Symptom Assessment Scale (ESAS). Scale is from a 0 to 90, with higher scores indicating higher symptom burden. | This analysis included participants who completed the six-week study. The number of participants analyzed at each time point varied because:
| Posted | Mean | Standard Deviation | score on a scale | At baseline and weekly for 6 weeks. |
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| Secondary | Number of Patient Hospitalizations From Enrollment to End of Intervention | All hospitalizations of the caregivers' patient from enrollment to end of intervention | This data was unable to be collected because we didn't have access to the patients' medical records after they were discharged to accurately determine whether they were hospitalized after hospice discharge. | Posted | From enrollment to the end of the intervention or at 6 weeks, which ever is earlier. |
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| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | I-HoME Intervention | Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. I-HoME: I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Week 1 ESAS Score |
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| Week 2 ESAS Score |
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| Week 3 ESAS Score |
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| Week 4 ESAS Score |
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| Week 5 ESAS Score |
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| Week 6 ESAS Score |
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