Trial Outcomes & Findings for Palliative Care at Home for Dementia (NCT NCT03798327)
NCT ID: NCT03798327
Last Updated: 2025-06-18
Results Overview
Number of Patients who completed the SM-EOLD Assessment Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 3 months, 6 months
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
Home Palliative Care - Patients
Home Palliative Care: Patients will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
Home Palliative Care - Caregiver
Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Caregiver
Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
Baseline characteristics by cohort
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
Home Palliative Care - Caregivers
n=14 Participants
Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Caregivers
n=16 Participants
Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Patients
|
81.9 years
STANDARD_DEVIATION 0.75 • n=14 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
83.4 years
STANDARD_DEVIATION 0.75 • n=16 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
—
|
—
|
82.7 years
STANDARD_DEVIATION 1.1 • n=30 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
|
Age, Continuous
Caregivers
|
—
|
—
|
59.2 years
STANDARD_DEVIATION 0.85 • n=14 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
58.0 years
STANDARD_DEVIATION 0.85 • n=16 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
58.6 years
STANDARD_DEVIATION 14.3 • n=30 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=14 Participants
|
12 Participants
n=16 Participants
|
11 Participants
n=14 Participants
|
11 Participants
n=16 Participants
|
44 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
12 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
4 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
5 Participants
n=16 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
13 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
8 Participants
n=14 Participants
|
9 Participants
n=16 Participants
|
34 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
13 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
7 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=14 Participants
|
9 Participants
n=16 Participants
|
6 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
30 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=14 Participants
|
8 Participants
n=16 Participants
|
19 Participants
n=60 Participants
|
|
Number of Participants who lives alone
|
2 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
7 Participants
n=60 Participants
|
|
Highest Education obtained
Less than high school diploma/GED
|
2 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
6 Participants
n=60 Participants
|
|
Highest Education obtained
High school diploma/GED or greater
|
6 Participants
n=14 Participants
|
8 Participants
n=16 Participants
|
5 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
25 Participants
n=60 Participants
|
|
Highest Education obtained
Missing
|
6 Participants
n=14 Participants
|
4 Participants
n=16 Participants
|
9 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
29 Participants
n=60 Participants
|
|
Marital Status
Married
|
—
|
—
|
6 Participants
n=14 Participants • Data collected for caregivers only.
|
7 Participants
n=16 Participants • Data collected for caregivers only.
|
13 Participants
n=30 Participants • Data collected for caregivers only.
|
|
Marital Status
Divorced
|
—
|
—
|
1 Participants
n=14 Participants • Data collected for caregivers only.
|
1 Participants
n=16 Participants • Data collected for caregivers only.
|
2 Participants
n=30 Participants • Data collected for caregivers only.
|
|
Marital Status
Single
|
—
|
—
|
1 Participants
n=14 Participants • Data collected for caregivers only.
|
3 Participants
n=16 Participants • Data collected for caregivers only.
|
4 Participants
n=30 Participants • Data collected for caregivers only.
|
|
Marital Status
Missing
|
—
|
—
|
6 Participants
n=14 Participants • Data collected for caregivers only.
|
5 Participants
n=16 Participants • Data collected for caregivers only.
|
11 Participants
n=30 Participants • Data collected for caregivers only.
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsNumber of Patients who completed the SM-EOLD Assessment Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
Baseline Admission
|
14 Participants
|
16 Participants
|
|
Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
3 months
|
6 Participants
|
5 Participants
|
|
Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
6 months
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsNumber of Patients who completed the McGill Quality of Life Assessment McGill Quality of Life instrument is assessment in the domains of physical symptoms, emotional well-being, social interactions, and an overall global rating. Alzheimer's Disease Scale: Quality of Life - Likert scale, 13 items, each 1-4. Total scale from 13- 52. Higher values are more positive scores.
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Number of Patients Who Completed the McGill Quality of Life Assessment
Baseline - Admission
|
14 Participants
|
15 Participants
|
|
Number of Patients Who Completed the McGill Quality of Life Assessment
3 months
|
6 Participants
|
5 Participants
|
|
Number of Patients Who Completed the McGill Quality of Life Assessment
6 months
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe Study Team will examine the patient's chart for completion of advanced directives Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsThe Study Team will examine if the care patients receive is concordant with the care they wanted to receive. Scale: Simple chart review of whether care received matches stated preferences (yes/no)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsNumber of Caregivers who completed the Caregiver Zaria Burden Inventory Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point scale range from 0 (never) to 4 (always) Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
Baseline - admissions
|
13 Participants
|
13 Participants
|
|
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
3 months
|
6 Participants
|
3 Participants
|
|
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
6 months
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsNumber of Caregivers who completed the FAMCARE-10 Assessment FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Number of Caregivers Who Completed the FAMCARE-10 Assessment
Baseline - Admissions
|
13 Participants
|
13 Participants
|
|
Number of Caregivers Who Completed the FAMCARE-10 Assessment
3 months
|
6 Participants
|
3 Participants
|
|
Number of Caregivers Who Completed the FAMCARE-10 Assessment
6 months
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsNumber of Caregivers who completed the Patient Health Questionnaire (PHQ-9) PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression \[Time Frame: 6 months\]
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)
6 months
|
2 Participants
|
5 Participants
|
|
Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)
Baseline - Admissions
|
13 Participants
|
14 Participants
|
|
Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)
3 months
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsHealthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Mean Change in Number of Hospital Admissions
|
0 admissions
Standard Deviation 0.6
|
0.5 admissions
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 6 monthsPatient healthcare utilization as assessed by hospital length of stay over the past 6 months
Outcome measures
| Measure |
Home Palliative Care - Patients
n=14 Participants
Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
|
Usual Care - Control Arm - Patients
n=16 Participants
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
|
|---|---|---|
|
Hospital Length of Stay
|
0 days
Standard Deviation 1.7
|
1.3 days
Standard Deviation 2.9
|
Adverse Events
Home Palliative Care - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care - Control Arm - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Palliative Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nathan Goldstein
Icahn School of Medicine at Mount Sinai
Phone: 212-844-1712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place