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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year, two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year, two years
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
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,473 Previous Clinical Trials
17,501,680 Total Patients Enrolled
11 Trials studying Dementia
2,456 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,313 Total Patients Enrolled
292 Trials studying Dementia
23,634,279 Patients Enrolled for Dementia
VJ Periyakoil, MDPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
1,000 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own medical decisions and do not need a proxy.All caregivers involved with the Stanford Alzheimer's Disease Research Center (SADRC).I have severe dementia and cannot respond to basic questions or instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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