NCT06276452

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Mar 2024Nov 2026

First Submitted

Initial submission to the registry

February 16, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

March 9, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

February 16, 2024

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Supporting resilience psychoeducational group

EXPERIMENTAL

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.

Behavioral: Psychoeducation

Interventions

PsychoeducationBEHAVIORAL

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

Supporting resilience psychoeducational group

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Legacy Reentry

Louisville, Kentucky, 40203, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stephanie Grace Prost, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 26, 2024

Study Start

March 9, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations