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Supportive Care for Cognitively Impaired Patients and Families

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Stanford University

Status

Active, not recruiting

Conditions

Primary Palliative Care
Mild Cognitive Impairment
Dementia

Treatments

Behavioral: nurse-led supportive care assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03881579
48000
R01AG062239-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Usual care
Other group
Description:
one random half of patients will receive usual care
Treatment:
Behavioral: nurse-led supportive care assessment
intervention arm
Experimental group
Description:
one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)
Treatment:
Behavioral: nurse-led supportive care assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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