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Home Palliative Care for Dementia

N/A
Recruiting
Led By Laura P Gelfman, MD, MPH
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study a new model of at-home palliative care for dementia patients and their family caregivers in NYC. Patients will be randomly assigned to the intervention or control group.

Who is the study for?
This trial is for patients over 64 years old with advanced dementia (GDS > 6) living in Manhattan, not in long-term care. They must have had a hospital visit within the last year and have a primary physician from one of the four Mount Sinai sites. A family caregiver must be willing to enroll and either patient or caregiver should speak English or Spanish.
What is being tested?
The study tests an innovative home palliative care model for those with advanced dementia. Participants are randomly assigned to receive this new care approach at home or an augmented standard control, comparing outcomes across multiple New York City hospitals.
What are the potential side effects?
Since this trial involves non-medical intervention focusing on comfort rather than treatment, traditional side effects like those seen with medications are not expected. However, emotional or psychological impacts may occur due to changes in care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptom Management as measured by the End of Life for Dementia scale
Secondary study objectives
Caregiver burden per Zarit Burden Inventory
Caregiver depression measured by PHQ-9 Score
Caregiver satisfaction measured using FAMCARE-10
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Palliative care at homeExperimental Treatment1 Intervention
Randomized to intervention arm
Group II: Augmented controlActive Control1 Intervention
Randomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Palliative Care
2018
N/A
~240

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,505 Total Patients Enrolled
9 Trials studying Dementia
630 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,032 Total Patients Enrolled
292 Trials studying Dementia
23,634,179 Patients Enrolled for Dementia
Laura P Gelfman, MD, MPHPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Home Palliative Care Clinical Trial Eligibility Overview. Trial Name: NCT05749146 — N/A
Dementia Research Study Groups: Palliative care at home, Augmented control
Dementia Clinical Trial 2023: Home Palliative Care Highlights & Side Effects. Trial Name: NCT05749146 — N/A
Home Palliative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05749146 — N/A
~191 spots leftby May 2027
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