DementiaNCT05749146
Palliative Care for Patients With Dementia
A study testing Home Palliative Care in people with Dementia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Home Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have advanced dementia, based on Global Deterioration Score (GDS)>6
- impairment in at least one activity of daily living (ADL -which is inherent in this level of GDS)
- at least one hospitalization or ED visit within the last 12 months
- a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four Mount Sinai sites in Manhattan
- a family caregiver willing to enroll
- a residence in Manhattan where they are currently living (not in a long-term care facility)
Show all 9Show fewer
- capacity to consent or a legal representative available to provide consent
- fluency in English or Spanish, or their legal representative must be fluent in English or Spanish
- age >64.
Who cannot join
- Does not have a family caregiver to enroll
- Does not reside in Manhattan outside of long-term care facility
- Does not have fluency in English or Spanish Doesn't
Trial locations and contacts
1 site in 1 country.
United States1 site
Ichan School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Palliative Care at Home for Patients With Dementia and Their Caregivers
A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.
Read the 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.
- Conditions
- Dementia
- Being tested
- Home Palliative Care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Palliative CareBehavioural
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
| Study group | Role | What they receive |
|---|---|---|
| Palliative care at home | Experimental | Randomized to intervention arm Receives: Behavioral: Home Palliative Care |
| Augmented control | Active comparator | Randomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care) Receives: Behavioral: Home Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Management as measured by the End of Life for Dementia scale
This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator. The Symptom Management at the End of Life in Dementia (SM-EOLD) scale responses range from 0 to 45 with higher scores indicating better symptom management.
Measured: 6 months
Secondary outcomes (10)
Number of Hospital Admissions
Acute care utilization as measured by the number of hospital admissions
Measured: at 12 months
Number of Hospital Stays
Acute care utilization as measured by the number of hospital days
Measured: at 12 months
Patient reported treatment concordance
The Study Team will examine if the care patients receive is concordant with the care they wanted to receive using simple chart review of whether care received matches stated preferences (yes/no).
Measured: at 12 months
Cost Analysis
Total costs between the arms including inpatient, emergency department, ambulatory services, and home care services will be compared. Costs of the clinical intervention (e.g. clinical personnel, transportation) will be included in the analyses.
Measured: at 12 months
Caregiver burden per Zarit 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). Full scale from 22 - 110, higher score indicates a greater burden.
Measured: at 6 months
Caregiver burden per Zarit 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). Full scale from 22 - 110, higher score indicates a greater burden.
Measured: at 12 months
Caregiver satisfaction measured using FAMCARE-10
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. Full scale ranges 0-20, with higher scores indicating higher satisfaction.
Measured: at 6 months
Caregiver satisfaction measured using FAMCARE-10
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. Full scale ranges 0-20, with higher scores indicating higher satisfaction.
Measured: at 12 months
Caregiver depression measured by PHQ-9 Score
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). Full scale from 0-27, with higher score indicating more severe symptoms.
Measured: at 6 months
Caregiver depression measured by PHQ-9 Score
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). Full scale from 0-27, with higher score indicating more severe symptoms.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start8 Jun 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects assigned to intervention or control arms in a 1:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Laura Gelfman, Icahn School of Medicine at Mount Sinai
- Investigators
- Laura P Gelfman, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749146
- Sponsor's protocol ID
- GCO 19-1232
- Other IDs
- R01AG067045
- Status last verified
- May 2026
- First submitted
- 18 Feb 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care at Home for Patients With Dementia and Their Caregivers
- ClinicalTrials.gov ID
- NCT05749146
- Acronym / sponsor ID
- GCO 19-1232
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects assigned to intervention or control arms in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Palliative care at home | Experimental | Behavioral: Home Palliative CareRandomized to intervention arm |
| Augmented control | Active comparator | Behavioral: Home Palliative CareRandomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- have advanced dementia, based on Global Deterioration Score (GDS)>6
- impairment in at least one activity of daily living (ADL -which is inherent in this level of GDS)
- at least one hospitalization or ED visit within the last 12 months
- a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four Mount Sinai sites in Manhattan
- a family caregiver willing to enroll
Key exclusion criteria (3 listed)
- Does not have a family caregiver to enroll
- Does not reside in Manhattan outside of long-term care facility
- Does not have fluency in English or Spanish Doesn't
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Palliative CarePatients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. | Behavioural | Augmented control, Palliative care at home |
Primary outcome
Symptom Management as measured by the End of Life for Dementia scale
Time frame: 6 months
This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator. The Symptom Management at the End of Life in Dementia (SM-EOLD) scale responses range from 0 to 45 with higher scores indicating better symptom management.
10 secondary outcomes
Number of Hospital Admissions
Time frame: at 12 months
Number of Hospital Stays
Time frame: at 12 months
Patient reported treatment concordance
Time frame: at 12 months
Cost Analysis
Time frame: at 12 months
Caregiver burden per Zarit Burden Inventory
Time frame: at 6 months
Caregiver burden per Zarit Burden Inventory
Time frame: at 12 months
Caregiver satisfaction measured using FAMCARE-10
Time frame: at 6 months
Caregiver satisfaction measured using FAMCARE-10
Time frame: at 12 months
Caregiver depression measured by PHQ-9 Score
Time frame: at 6 months
Caregiver depression measured by PHQ-9 Score
Time frame: at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura P Gelfman, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Palliative Care in people with Dementia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Management as measured by the End of Life for Dementia scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.