N/A
N=60
Palliative Care at Home for Dementia
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03798327 ↗Enrolled (actual)
60
Serious AEs
—
Results posted
Jun 2025
Primary outcome: Primary: Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) — 14; 16; 6; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home Palliative Care (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) |
14; 16; 6; 5; 2; 7 | — |
| SECONDARY Number of Patients Who Completed the McGill Quality of Life Assessment |
14; 15; 6; 5; 2; 7 | — |
| SECONDARY Number of Complete of Advance Directives |
— | — |
| SECONDARY Preference Consistent Care |
— | — |
| SECONDARY Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory |
13; 13; 6; 3; 2; 5 | — |
| SECONDARY Number of Caregivers Who Completed the FAMCARE-10 Assessment |
13; 13; 6; 3; 2; 5 | — |
| SECONDARY Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) |
13; 14; 6; 3; 2; 5 | — |
| SECONDARY Mean Change in Number of Hospital Admissions |
0; 0.5 | — |
| SECONDARY Hospital Length of Stay |
0; 1.3 | — |
Summary
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for 6 months.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
Eligibility Criteria
Inclusion Criteria
- Presence of advanced dementia
- Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
- Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
- Subject has evidence of capacity to benefit from enrollment in palliative care program
- Subject is conversant in English or Spanish
- Subject has capacity to consent or has a caregiver who can provide consent for the patient
Exclusion Criteria
- Subject has no usual physician within Mount Sinai
- Subject's usual physician doesn't provide authorization to patient participation
- Subject resident outside of Manhattan or in long term care facility or receiving hospice
- Subject is not conversant in English or Spanish
- Subject cannot provide consent or has no caregiver who can provide consent
Data sourced from ClinicalTrials.gov (NCT03798327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.