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Home Palliative Care for Dementia
N/A
Recruiting
Led By Nathan Goldstein, MD
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 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptom Management as measured by the End of Life for Dementia scale
Secondary outcome measures
Caregiver burden per Zarit Burden Inventory
Caregiver depression measured by PHQ-9 Score
Caregiver satisfaction measured using FAMCARE-10
+4 moreTrial 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
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,326 Total Patients Enrolled
7 Trials studying Dementia
520 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,585 Total Patients Enrolled
268 Trials studying Dementia
23,627,306 Patients Enrolled for Dementia
Nathan Goldstein, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
796 Total Patients Enrolled
1 Trials studying Dementia
41 Patients Enrolled for Dementia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need help with daily activities like dressing or bathing.I have been hospitalized or visited the ER in the past year.I can make my own medical decisions or have someone who can.I or my legal representative can communicate fluently in English or Spanish.I am 65 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Palliative care at home
- Group 2: Augmented control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment presently enrolling participants?
"As indicated on clinicaltrials.gov, the trial is not presently seeking participants. The project was first posted in March of 2023 and has since been updated as recently as February 18th, however there are currently 396 other trials actively recruiting patients."
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