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Supportive Care for Cognitively Impaired Patients and Families

NCT ID: NCT03881579

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Dementia Primary Palliative Care Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes will be assessed by blinded research associates

Study Groups

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Usual care

one random half of patients will receive usual care

Group Type OTHER

nurse-led supportive care assessment

Intervention Type BEHAVIORAL

Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

intervention arm

one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)

Group Type EXPERIMENTAL

nurse-led supportive care assessment

Intervention Type BEHAVIORAL

Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

Interventions

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nurse-led supportive care assessment

Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
* All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).

Exclusion Criteria

1. Institutionalized (not a community dweller) at the time of entry into the study;
2. 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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VJ Periyakoil

Director. Palliative Care Education & Training

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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VJ Periyakoil, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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VJ Periyakoil

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG062239-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

48000

Identifier Type: -

Identifier Source: org_study_id