NCT05497882

Brief Summary

The mission of corrections is to provide care, custody, and control for incarcerated individuals. United States prisons are required by law to provide adequate care for growing numbers of older people who are incarcerated-a group who are disproportionately at risk for Alzheimer's Disease and Related Dementias (ADRD). This Phase I project focuses on research and development of highly interactive computer-based learning modules, for prison staff and people who are incarcerated and serving as peer caregivers, to promote an integrated systems approach for enhancing the care of people with ADRD in prison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

July 27, 2022

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Focus Groups

    Focus groups will be conducted with interdisciplinary staff and peer caregivers. Data evaluation will include content and thematic analysis using constant comparative analyses methods.

    Focus groups will conducted in year 1. The analysis will be completed in Year 1 immediately following the conduct of the focus groups.

  • System Usability Scale

    The System Usability Scale is a validated tool for assessing the usability and acceptability of technological products. Items on the System Usability Scale are rated from 1 (minimum) to 5 (maximum) with the higher number representing the better outcome.

    The usability test will be conducted in Year 1 and system usability scale will be administered in Year 1 following the conduct of the usability test.

Study Arms (1)

Training Prototype

EXPERIMENTAL

Testing of 3 e-learning modules

Behavioral: E-Learning Prototype for Dementia Care

Interventions

Usability testing System Usability Scale

Training Prototype

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prison staff:
  • work at a participating prison;
  • care for or manage people with ADRD in prison;
  • able to speak, understand and read English;
  • able to consent.
  • Inmates:
  • have experience in caregiving;
  • able to speak, understand and read English;
  • able to consent.

You may not qualify if:

  • Prison staff:
  • not work at a participating prison;
  • do not care for or manage people with ADRD in prison;
  • cannot speak, understand or read English,
  • unable to consent.
  • Inmates:
  • do not have experience in caregiving;
  • cannot speak, understand or read English,
  • unable to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barbara Walkosz

Golden, Colorado, 80401, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Susan Loeb

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: this is not a clinical trial.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 11, 2022

Study Start

January 20, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations