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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year, two years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in Patient Activation Measure over time
Differences in Edmonton Symptoms Assessment Scale (ESAS) scores
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
2,374 Previous Clinical Trials
17,332,727 Total Patients Enrolled
11 Trials studying Dementia
2,456 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,003,970 Total Patients Enrolled
263 Trials studying Dementia
23,622,891 Patients Enrolled for Dementia
VJ Periyakoil, MDPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment accepting new participants?
"Unfortunately, based on the information available online at clinicaltrials.gov this trial is not currently seeking new enrollees. The listing was first created on December 18th 2019 and last modified on June 7th 2022; however, there are 401 other medical studies that presently require candidates to participate."
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