Palliative Care at Home for Dementia
Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home
2 other identifiers
interventional
60
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2022
CompletedResults Posted
Study results publicly available
June 18, 2025
CompletedJune 18, 2025
June 1, 2025
3.5 years
January 7, 2019
October 3, 2024
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
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
Baseline, 3 months, 6 months
Secondary Outcomes (8)
Number of Patients Who Completed the McGill Quality of Life Assessment
Baseline, 3 months, 6 months
Number of Complete of Advance Directives
6 months
Preference Consistent Care
6 months
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
Baseline, 3 months, 6 months
Number of Caregivers Who Completed the FAMCARE-10 Assessment
Baseline, 3 months, 6 months
- +3 more secondary outcomes
Study Arms (2)
Home Palliative Care
EXPERIMENTALRandomized to Intervention Arm
Control Arm
NO INTERVENTIONUsual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
Interventions
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Mount Sinai Beth Israel
New York, New York, 10003, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai St. Luke's
New York, New York, 10025, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
Estrada LV, Gelfman L, Zhang M, Espino C, Goldstein N. Challenges and solutions of conducting dementia clinical trials: A palliative care at home pilot for persons with dementia. J Am Geriatr Soc. 2024 Aug;72(8):2544-2551. doi: 10.1111/jgs.18966. Epub 2024 May 22.
PMID: 38777615BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nathan Goldstein
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- STUDY DIRECTOR
Nathan Goldstein, MD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single blind control
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Geriatrics and Palliative Medicine
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 9, 2019
Study Start
November 1, 2018
Primary Completion
April 29, 2022
Study Completion
April 29, 2022
Last Updated
June 18, 2025
Results First Posted
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share