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PLAN Program for Dementia (PLAN Trial)
N/A
Recruiting
Led By Hae-Ra Han, PhD, RN
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 65 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PLAN Trial Summary
This trial is being done to study whether an education and navigation support program helps Korean American elders with probable dementia and their caregivers.
Who is the study for?
This trial is for first-generation Korean American elders aged 65+, with probable dementia but no formal diagnosis, and who have a caregiver interacting weekly. They must be able to consent or have someone who can on their behalf. Those already diagnosed with dementia, other major mental health conditions, neurological issues affecting cognition, or on antipsychotics cannot join.Check my eligibility
What is being tested?
The study tests an education and support program (PLAN) by community health workers against standard care for improving dementia care linkage and caregivers' abilities in managing the condition. It's a randomized controlled trial involving dyads of elders and caregivers to see if PLAN improves outcomes like literacy, self-efficacy, social support, quality of life, and depression levels.See study design
What are the potential side effects?
Since this intervention involves educational support rather than medication there are no direct medical side effects; however participants may experience emotional distress or fatigue from engaging in the program.
PLAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
PLAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants linked to medical service for dementia measured by medical record verification
Secondary outcome measures
Caregiver's dementia literacy measured by dementia literacy test
Depression status as assessed by Patient Health Questionnaire-9
Dementia
+2 morePLAN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PLAN (intervention)Experimental Treatment1 Intervention
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
Group II: Standard of care (control)Active Control1 Intervention
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,209 Total Patients Enrolled
31 Trials studying Dementia
82,450 Patients Enrolled for Dementia
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,588 Total Patients Enrolled
21 Trials studying Dementia
10,711 Patients Enrolled for Dementia
NYU Langone HealthOTHER
1,369 Previous Clinical Trials
840,310 Total Patients Enrolled
17 Trials studying Dementia
67,665 Patients Enrolled for Dementia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no cognitive impairments other than Alzheimer's disease.This criterion means the participant must have a certain level of disease severity (CDR 1.0+).I am currently taking medication for mental health issues.You have a diagnosis of a depressive disorder, but not of schizophrenia, bipolar disorder, or substance use disorder.You have been diagnosed with dementia in the past.You identify as a first-generation Korean American.I am 65 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PLAN (intervention)
- Group 2: Standard of care (control)
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.
Are there still available slots to partake in this research initiative?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initially announced on April 20th 2021, is actively searching for participants. A total of 288 subjects need to be recruited at 2 different medical facilities."
Answered by AI
What is the size of the cohort involved in this research?
"Affirmative. Details on clinicaltrials.gov suggest that this medical research, which was initially posted on April 20th 2021 and recently updated July 21st 2022, is actively recruiting participants. This trial requires 288 people to take part across two distinct sites."
Answered by AI
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