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Advance Care PlanningAEGISNCT07824245

Advancing Ethical Goals In Society Trial

A study testing ACP Counselor Video Program in people with Advance Care Planning and Dementia, run by Tufts Medical Center at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
ACP Counselor Video Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,174 participants
Where
2 sitesUnited States
Study dates
1 Mar 2027to 1 Mar 2031
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

  • as ascertained within a month of randomization
  • Age ≥65 years as of the cohort eligibility/index date
  • At least one qualifying ambulatory encounter during the 12-month assessment window
  • One of the following
  • Diagnosed with Alzheimer's Disease or Related Dementias (ADRD) based on a pre-specified ICD-10 code list, or
  • Estimated 1-year mortality risk of at least 20%, based on a prespecified health-system mortality-risk algorithm, or
  • Age 90 and above

Who cannot join

  • Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
  • Patients who primarily reside in a skilled nursing facility
  • Incarcerated patients

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Diya Patel, Bachelors contact

774-218-6634

diya.patel1@tuftsmedicine.org

Carly Bridden contact

Carly.Bridden@tuftsmedicine.org

United States2 sites
  • Dartmouth Health

    Lebanon, New Hampshire, 03756

    Lori Henault, 617-869-3324, lori.e.henault@hitchcock.org

    Angelo E Volandes

  • Northwell Health

    New Hyde Park, New York, 11042

    Christian Nouryan, 516-273-8699, CNouryan@northwell.edu

    Edith Burns

Other trials in United States

About this study

Official title: ACP Educator Video Program to Promote Goal-Concordant Care in Older Patients and Those With Alzheimer's Disease and Related Dementias: Advancing Ethical Goals In Society (AEGIS)

The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. The main aims of the study are:

  • To assess the impact of our Advance Care Planning (ACP) Counselor Video Program on ACP documentation and receipt of goal-concordant care in a diverse sample of older adults with ADRD or other serious illness
  • To compare resuscitation preferences, hospice use, healthcare utilization and costs
Read more

Researchers will randomize participants into two groups. All participants will continue to receive routine care. Participants randomized to the Immediate-Start Intervention group will be offered the ACP Counselor Video Program during both Phase 1 and Phase 2. Participants randomized to the Routine Care/Delayed-Start Intervention group will receive routine care alone during Phase 1 and will be offered the ACP Counselor Video Program beginning in Phase 2. Each phase will last two years. Both groups will have access to the intervention during Phase 2.

During the intervention, participants will:

  • Meet with ACP counselors
  • Watch ACP videos.
Being tested
ACP Counselor Video Program
Keywords
ADRD, dissemination and implementation science, Goal Concordant Care
Medical subject headings
Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACP Counselor Video ProgramOther

    Participants will meet with ACP counselors to talk about their goals of care. Participants and surrogates will watch and discuss videos about ACP options with the ACP counselor.

Study groups in NCT07824245
Study groupRoleWhat they receive
Immediate-Start InterventionExperimentalParticipants in this arm will be offered the ACP Counselor Video Program in addition to routine care during both Phase 1 and Phase 2.
Receives: Other: ACP Counselor Video Program
Routine Care/Delayed-Start InterventionOtherParticipants in the Routine Care/Delayed-Start Intervention arm will receive routine care during the first two years and are then given access to the intervention (ACP Counselor Video Program) for two years.
Receives: Other: ACP Counselor Video Program

What is being measured

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

  1. Presence of qualifying ACP documentation by the end of Phase 1

    This outcome will be the percentage of participants with qualifying ACP documentation. Qualifying ACP documentation is defined as ACP documentation that is newly created or updated during Phase 1.

    Measured: From randomization through the end of Phase 1 (24 months).

  2. Occurrence of adjudicated goal-concordant care during the last 3 months of life

    This outcome is defined to be the percentage of decedents classified as having goal-concordant care.

    Measured: Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.

Timeline

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

  1. First posted17 Sep 2026
  2. Study start1 Mar 2027 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Mar 2031 (estimated)

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
Pragmatic, randomized, delayed-start trial with routine care as the control during the first 24 months
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12,174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824245
Sponsor's protocol ID
00006552
Other IDs
1U19AG090271-01A1, 535804
Acronym
AEGIS
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will create a deidentified data set that will be preserved and shared. The purpose of creating this is to allow other investigators access to the data to advance inquiry in the field. We share the NIH's goal for sharing data to allow scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health. To this end, we will make study data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following NIH Public Access Policy guidelines. We will investigate opportunities for public forums, including those provided by the NIH. We will include a data dictionary for all original and derived data elements, administrative guidance for tool administration, intervention protocol documentation, qualitative coding documentation, as well as all publications using it.

Questions about this trial

What is this clinical trial studying?

A study testing ACP Counselor Video Program in people with Advance Care Planning and Dementia, run by Tufts Medical Center at 2 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 7 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

Contact Diya Patel, Bachelors (774-218-6634, diya.patel1@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of qualifying ACP documentation by the end of Phase 1 (time frame: From randomization through the end of Phase 1 (24 months).). The study lists 2 primary outcomes in all. 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 17 Sep 2026.

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