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Peer Navigation for Psychiatric Disabilities (DRRRP-PHN Trial)
N/A
Recruiting
Led By Patrick W Corrigan, PsyD
Research Sponsored by Illinois Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months, 8 months, 12 months
Awards & highlights
DRRRP-PHN Trial Summary
This trial will test whether a peer navigator program can help adults with psychiatric disabilities improve their physical health and wellness.
Who is the study for?
This trial is for adults over 18 with serious mental illness who want to improve their physical health and wellness. They must be active members of Thresholds in the Chicago South Side area, willing to attend sessions but not already receiving peer support or Assertive Community Treatment services.Check my eligibility
What is being tested?
The study tests a Peer Navigator Program (PNP) against usual integrated care. PNP uses peers with similar backgrounds and recovery experiences to help participants navigate healthcare services. The goal is better engagement, health, recovery, and quality of life.See study design
What are the potential side effects?
Since this intervention involves peer navigation rather than medication, traditional side effects are not expected. However, there may be emotional or social impacts due to the nature of personal interactions within the program.
DRRRP-PHN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
DRRRP-PHN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 months, 8 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months, 8 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12
Secondary outcome measures
Change from Baseline in COVID-19 Social Distancing and Hygiene Scale Scores at Months 4, 8, and 12
Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
+7 moreDRRRP-PHN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Peer Navigator Program (PNP)Experimental Treatment1 Intervention
Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
scheduling and attending healthcare appointments;
partnering with participant on tasks that arise from appointments;
health-related goal setting; and
taking action-steps toward health-related goals.
Group II: Treatment as Usual-Integrated Care (TAU-IC)Active Control1 Intervention
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-half of research participants will be randomized to integrated care alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peer Navigation
2016
N/A
~870
Find a Location
Who is running the clinical trial?
Arizona State UniversityOTHER
283 Previous Clinical Trials
109,160 Total Patients Enrolled
Illinois Institute of TechnologyLead Sponsor
23 Previous Clinical Trials
16,744 Total Patients Enrolled
Thresholds Inc.Industry Sponsor
3 Previous Clinical Trials
455 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I want to better my health and prevent illness with the help of a health guide.I am currently getting support from a community mental health team.I am working with a peer support specialist on my health goals.I want to better my health and prevent illness with the help of a health guide.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual-Integrated Care (TAU-IC)
- Group 2: Peer Navigator Program (PNP)
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.
Psychiatric Disorder Patient Testimony for trial: Trial Name: NCT05018351 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team actively searching for participants?
"That is correct. The information posted to clinicaltrials.gov confirms that this medical trial has been actively seeking candidates since it was initially published on May 17th 2021 and most recently updated on March 30th 2022. 354 individuals are needed between two medical centres for the research."
Answered by AI
What is the sample size for this clinical investigation?
"Affirmative. According to the information provided on clinicialtrials.gov, this experiment is actively recruiting participants since its posting date of May 17th 2021 and most recent update happening in March 30th 2022. The team behind it needs 354 people between two sites for their research purposes."
Answered by AI
What is the goal this trial seeks to accomplish?
"The primary endpoint of the trial is to evaluate the difference in Texas Christian University Health Form (TCU-HLTHFORM) scores at Months 4, 8 and 12 compared with Baseline. Secondary objectives include assessing Change from Baseline in Health Literacy Questionnaire (HLQ) Scores at Months 4, 8 and 12 - three scales measuring active health management, engagement with healthcare providers as well as navigating the healthcare system; Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8 and 12 - score ranging between 0 and 30 which will"
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Illinois Institute of Technology
Thresholds
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I'm trying to get help and make some money while attempting to do so. Well to help with my own blood pressure and maybe do something for others.
PatientReceived 1 prior treatment
I am interested in the Peer Navigation for people with psychiatric disorders study. I want to make a change in order to eat and exercise better.
PatientReceived 1 prior treatment
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