- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06276452
Supporting Resilience Among Re-entered Seniors (SRRS)
The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.
Aim 1 participants will:
- complete a baseline survey
- participate in a focus group
Aim 2 participants will:
- complete a baseline survey
- participate in an 8-week once weekly intervention
- complete three follow up surveys
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Grace Prost, PhD
- Phone Number: 850-491-0285
- Email: stephanie.prost@louisville.edu
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40203
- Recruiting
- New Legacy Reentry
-
Contact:
- Stephanie Grace Prost, PhD
- Email: stephanie.prost@louisville.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 45 years old
- have re-entered the community from a period of incarceration from jail or prison
- have at least one chronic health condition
- able to speak and understand English
Exclusion Criteria:
- aged 44 or younger
- have not re-entered the community from a period of incarceration from jail or prison
- does not have at least one chronic health condition
- unable to speak and understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supporting resilience psychoeducational group
This group-based psychoeducational intervention will take place once weekly for eight weeks and will be centered upon building older adults' knowledge, skills, and motivation to manage chronic disease.
|
Psychoeducation is the therapeutic management of illness through the increase of related knowledge, skills, and motivation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic disease self managment
Time Frame: 12 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions measures (viz.
daily activities, medications and treatments, symptoms, emotions, social interactions)
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23.0434
- U2CDA050097 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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