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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06276452
Other study ID # 23.0434
Secondary ID U2CDA050097
Status Recruiting
Phase N/A
First received
Last updated
Start date March 9, 2024
Est. completion date November 30, 2024

Study information

Verified date March 2024
Source University of Louisville
Contact Stephanie Grace Prost, PhD
Phone 850-491-0285
Email stephanie.prost@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The protocol for Aim 2 will be developed once the focus group data is analyzed.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychoeducation
Psychoeducation is the therapeutic management of illness through the increase of related knowledge, skills, and motivation.

Locations

Country Name City State
United States New Legacy Reentry Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic disease self managment 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
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