DementiaNCT03881579
Supportive Care for Cognitively Impaired Patients and Families
A study testing nurse-led supportive care assessment in people with Dementia and Primary Palliative Care, run by Stanford University at 1 site in United States.
Trial summary
Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Primary Palliative Care, Mild Cognitive Impairment
- What is being tested?
- nurse-led supportive care assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 31 Dec 2026
- 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
- All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
- All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
Who cannot join
- Institutionalized (not a community dweller) at the time of entry into the study;
- Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.
Read the detailed description
200 persons who participate in the Stanford ADRC will be recruited and randomized 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) elicit their goals of care and help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.
- Conditions
- Dementia, Primary Palliative Care, Mild Cognitive Impairment
- Being tested
- nurse-led supportive care assessment
- Keywords
- palliative, supportive, MCI, palliative care, supportive care, serious illness, RCT, randomized clinical trial, mild cognitive impairment, primary palliative care
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led supportive care assessmentBehavioural
Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | one random half of patients will receive usual care Receives: Behavioral: nurse-led supportive care assessment |
| intervention arm | Experimental | one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention) Receives: Behavioral: nurse-led supportive care assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the number of participants who express supportive care needs in both arms.
Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period).
We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses.
Measured: Day 0, 4 months, one year
Change in Zarit Caregiver Burden scores over time:
The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.
Measured: Day 0, 4 months, one year, 18 months
Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.
In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. We will monitor the EHR to track if the doctor documents goals of care in the chart.AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the doctor. Both forms have to be uploaded into the electronic health records.
Measured: Day 0, 4 months, one year, 18 months
Secondary outcomes (2)
Differences in Edmonton Symptoms Assessment Scale (ESAS) scores
The ESAS is designed to assist in the assessment of nine symptoms common in patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath, (there is also a line labelled "Other Problem"). The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. The investigators will assess change in ESAS score of all participants at baseline, months 4, 12 and 18. The investigators hypothesize that patients with cognitive impairment will have higher scores than those with normal cognition. The investigators will also determine changes in the ESAS score (if any) over time.
Measured: Day 0, 4 months, one year, 18 months
Change in Patient Activation Measure over time
3-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare.
PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change. PAM measures patient activation and agency: The investigators will assess changes in activation scores in ESAS scores between three points in time : on study entry, one year later and two year later.
Measured: one year, two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start18 Dec 2019
- Primary completion30 Nov 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized to one of two groups: 1\. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, VJ Periyakoil, Stanford University
- Investigators
- VJ Periyakoil, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881579
- Sponsor's protocol ID
- 48000
- Other IDs
- R01AG062239-01
- Status last verified
- Feb 2026
- First submitted
- 8 Oct 2018
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: this will depend on if patients consent or not for release of data
Publications
Periyakoil VS, Neri E, Mallari KIM, Huang HM, Padilla ED, Covinsky K, von Gunten CF, Kraemer H. Impact of a virtual nurse-led Early paLlIative Care IntervenTion (ELICIT) randomized controlled trial. NPJ Digit Med. 2026 Jun 25. doi: 10.1038/s41746-026-02935-5. Online ahead of print.
PubMed 42350622Periyakoil VS, Von Gunten C, Kraemer H. Virtual, Nurse-Led Early Primary Palliative Care Intervention (ELICIT) for Community-Dwelling Older Adults With Cognitive Impairment: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 24;14:e75082. doi: 10.2196/75082.
PubMed 41442238
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Care for Cognitively Impaired Patients and Families
- ClinicalTrials.gov ID
- NCT03881579
- Acronym / sponsor ID
- 48000
- Conditions
- Dementia, Primary Palliative Care, Mild Cognitive Impairment
- Keywords
- palliative, supportive, MCI, palliative care, supportive care, serious illness, RCT, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2019 (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.
Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.
Detailed description
200 persons who participate in the Stanford ADRC will be recruited and randomized 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) elicit their goals of care and help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patients will be randomized to one of two groups: 1. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Behavioral: nurse-led supportive care assessmentone random half of patients will receive usual care |
| intervention arm | Experimental | Behavioral: nurse-led supportive care assessmentone random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
- All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
Key exclusion criteria (2 listed)
- Institutionalized (not a community dweller) at the time of entry into the study;
- Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.
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 |
|---|---|---|
| nurse-led supportive care assessmentTrained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm | Behavioural | Usual care, intervention arm |
Primary outcome
To identify the number of participants who express supportive care needs in both arms.
Time frame: Day 0, 4 months, one year
Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period). We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses.
Change in Zarit Caregiver Burden scores over time:
Time frame: Day 0, 4 months, one year, 18 months
The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.
Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.
Time frame: Day 0, 4 months, one year, 18 months
In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. We will monitor the EHR to track if the doctor documents goals of care in the chart.AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the doctor. Both forms have to be uploaded into the electronic health records.
2 secondary outcomes
Differences in Edmonton Symptoms Assessment Scale (ESAS) scores
Time frame: Day 0, 4 months, one year, 18 months
Change in Patient Activation Measure over time
Time frame: one year, two years
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 3 Mar 2026.
- Derived from this study: PubMed 42350622Periyakoil VS, Neri E, Mallari KIM, Huang HM, Padilla ED, Covinsky K, von Gunten CF, Kraemer H. Impact of a virtual nurse-led Early paLlIative Care IntervenTion (ELICIT) randomized controlled trial. NPJ Digit Med. 2026 Jun 25. doi: 10.1038/s41746-026-02935-5. Online ahead of print.
- Derived from this study: PubMed 41442238Periyakoil VS, Von Gunten C, Kraemer H. Virtual, Nurse-Led Early Primary Palliative Care Intervention (ELICIT) for Community-Dwelling Older Adults With Cognitive Impairment: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 24;14:e75082. doi: 10.2196/75082.
- Individual participant dataSharing planned: Yes. this will depend on if patients consent or not for release of data
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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.
VJ Periyakoil, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led supportive care assessment in people with Dementia and Primary Palliative Care, run by Stanford University 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 2 inclusion and 2 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 3 Mar 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?
To identify the number of participants who express supportive care needs in both arms. (time frame: Day 0, 4 months, one year). The study lists 3 primary outcomes in all. 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 NCT03881579, which also lists 2 linked publications.
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 3 Mar 2026.