Trial Outcomes & Findings for Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice (NCT NCT04243538)
NCT ID: NCT04243538
Last Updated: 2025-08-07
Results Overview
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
COMPLETED
NA
80 participants
During recruitment (22 months)
2025-08-07
Participant Flow
Participant milestones
| Measure |
Control Arm
Standard of care.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Control Arm
Standard of care.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice
Baseline characteristics by cohort
| Measure |
Control Arm
n=40 Participants
Standard of care.
|
I-HoME Intervention
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Highest Education Completed
Some high school
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Highest Education Completed
High School or GED
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest Education Completed
Some College
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Highest Education Completed
College degree
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Highest Education Completed
Post-graduate but no degree
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Highest Education Completed
Graduate Degree
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Relationship to Patient
Spouse/partner
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Relationship to Patient
Child
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Relationship to Patient
Relative
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Relationship to Patient
Friend
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Annual Household Income Range
$25,000 or less
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Annual Household Income Range
$25,001 to $50,000
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Annual Household Income Range
$50,001 to $75,000
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Annual Household Income Range
$75,001 or greater
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Annual Household Income Range
Declined to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During recruitment (22 months)Population: 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.
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
Outcome measures
| Measure |
All Participants
n=212 Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Participant Recruitment Rate
|
37.7 percentage of enrolled participants
|
—
|
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: This measure includes all participants who were enrolled.
This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent.
Outcome measures
| Measure |
All Participants
n=40 Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=40 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Participant Attrition From Enrollment to End of Study
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
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.
Outcome measures
| Measure |
All Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=35 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Average Length of I-HoME Tele-visit
|
—
|
22.5 minutes
Standard Deviation 11.32
|
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
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.
Outcome measures
| Measure |
All Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=35 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants
|
—
|
23 videos
|
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
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.
Outcome measures
| Measure |
All Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=35 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
Reported Technical Issues
|
0 Participants
|
13 Participants
|
|
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
Did Not Report Technical Issues
|
0 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
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.
Outcome measures
| Measure |
All Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=35 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits.
|
—
|
89.6 percentage of tele-visits conducted out
|
SECONDARY outcome
Timeframe: At baseline and weekly for 6 weeks.Population: This analysis included participants who completed the six-week study. The number of participants analyzed at each time point varied because: 1. Caregiver attrition 2. The caregiver did not answer one or more questions on the survey 3. The caregiver was ineligible to participate due to their care recipient passing away or being discharged from hospice 4. Caregivers in the intervention arm missed the tele-visit session on that particular week
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.
Outcome measures
| Measure |
All Participants
n=34 Participants
This measure represents the recruitment rate for all participants.
|
I-HoME Intervention
n=17 Participants
I-HoME consists of two components: (1) a weekly tele-visit with a hospice nurse practitioner for up to 6 weeks, and (2) caregiver educational videos.
|
|---|---|---|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Baseline ESAS Score
|
39.0 score on a scale
Standard Deviation 13.9
|
43.7 score on a scale
Standard Deviation 17.6
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 3 ESAS Score
|
34.7 score on a scale
Standard Deviation 15.9
|
42.3 score on a scale
Standard Deviation 16.1
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 4 ESAS Score
|
34.9 score on a scale
Standard Deviation 16.5
|
38.8 score on a scale
Standard Deviation 19.2
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 1 ESAS Score
|
38.0 score on a scale
Standard Deviation 16.7
|
40.7 score on a scale
Standard Deviation 19.6
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 2 ESAS Score
|
34.6 score on a scale
Standard Deviation 15.1
|
42.5 score on a scale
Standard Deviation 16.8
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 5 ESAS Score
|
37.0 score on a scale
Standard Deviation 16.1
|
44.1 score on a scale
Standard Deviation 17.9
|
|
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Week 6 ESAS Score
|
36.1 score on a scale
Standard Deviation 15.6
|
39.9 score on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.Population: 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.
All hospitalizations of the caregivers' patient from enrollment to end of intervention
Outcome measures
Outcome data not reported
Adverse Events
Control Arm
I-HoME Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place