Palliative Care at Home for Dementia

Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Home Palliative Care

Detailed Description

The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.

Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.

Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai
    • New York, New York, United States, 10019
      • Mount Sinai West
    • New York, New York, United States, 10025
      • Mount Sinai St. Luke's
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Palliative Care; Randomized to Intervention Arm	Behavioral: 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.
No Intervention: Control Arm; Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complete of Advance Directives	The 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).	6 months
Preference Consistent Care	The 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)	6 months
Number of Patients Who Completed the McGill Quality of Life Assessment	Number 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.	Baseline, 3 months, 6 months
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory	Number 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	Baseline, 3 months, 6 months
Number of Caregivers Who Completed the FAMCARE-10 Assessment	Number 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	Baseline, 3 months, 6 months
Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)	Number 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]	Baseline, 3 months, 6 months
Mean Change in Number of Hospital Admissions	Healthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions	Baseline and 6 months
Hospital Length of Stay	Patient healthcare utilization as assessed by hospital length of stay over the past 6 months	6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Nathan Goldstein, MD, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Palliative Care; Home-Based Care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: GCO 17-02787; R56AG067045-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No