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Supportive Care for Dementia

N/A
Waitlist Available
Led By VJ Periyakoil, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Have severe dementia and are incapable of responding to the outcome measures at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year, two years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, and health care resource use for people with dementia living in the community.

Who is the study for?
This trial is for community-dwelling patients with dementia who are enrolled in the Stanford Alzheimer's Disease Research Center, along with their caregivers. It excludes those who are institutionalized, have severe dementia preventing them from responding to outcome measures, or lack a caregiver if unable to consent.
What is being tested?
The study tests a nurse-led supportive care assessment over 12 months aimed at improving symptoms and quality of life for people with dementia. The goal is also to reduce health care resource use by providing early palliative interventions.
What are the potential side effects?
Since this intervention involves supportive assessments rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience emotional or psychological impacts from discussing sensitive topics.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe dementia and cannot respond to basic questions or instructions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year, two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year, two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Zarit Caregiver Burden scores over time
Completion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.
To identify the number of participants who express supportive care needs in both arms.
Secondary study objectives
Change in Patient Activation Measure over time
Differences in Edmonton Symptoms Assessment Scale (ESAS) scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: intervention armExperimental Treatment1 Intervention
one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)
Group II: Usual careExperimental Treatment1 Intervention
one random half of patients will receive usual care

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,468 Previous Clinical Trials
17,496,082 Total Patients Enrolled
11 Trials studying Dementia
2,456 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,783 Previous Clinical Trials
28,184,023 Total Patients Enrolled
292 Trials studying Dementia
23,634,673 Patients Enrolled for Dementia
VJ Periyakoil, MDPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Media Library

nurse-led supportive care assessment Clinical Trial Eligibility Overview. Trial Name: NCT03881579 — N/A
Dementia Research Study Groups: Usual care, intervention arm
Dementia Clinical Trial 2023: nurse-led supportive care assessment Highlights & Side Effects. Trial Name: NCT03881579 — N/A
nurse-led supportive care assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03881579 — N/A
~3 spots leftby Dec 2024