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DementiaNCT03798327

Palliative Care at Home for Dementia

A study testing Home Palliative Care in people with Dementia, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesUnited States
Study dates
1 Nov 2018to 29 Apr 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai St. Luke's

    New York, New York, 10025

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

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
Keywords
Palliative Care, Home-Based 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 groups in NCT03798327
Study groupRoleWhat they receive
Home Palliative CareExperimentalRandomized to Intervention Arm
Receives: Behavioral: Home Palliative Care
Control ArmNo interventionUsual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 3 months, 6 months

  2. 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).

    Measured: 6 months

  3. 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)

    Measured: 6 months

  4. 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

    Measured: Baseline, 3 months, 6 months

  5. 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

    Measured: Baseline, 3 months, 6 months

  6. 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]

    Measured: Baseline, 3 months, 6 months

  7. 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

    Measured: Baseline and 6 months

  8. Hospital Length of Stay

    Patient healthcare utilization as assessed by hospital length of stay over the past 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start1 Nov 2018
  3. Primary completion29 Apr 2022
  4. Study completion29 Apr 2022

Resources

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
Patient - caregiver pairs
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798327
Sponsor's protocol ID
GCO 17-02787
Other IDs
R56AG067045-01
Status last verified
Jun 2025
First submitted
7 Jan 2019
Last updated
18 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38777615

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 4 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03798327, which also lists 1 linked publication.

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 18 Jun 2025.

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Palliative Care at Home for Dementia (NCT03798327) | AzTrials