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Aging ProblemsNCT03055429

Enhancing Care of the Aged and Dying in Prisons Ph II

A study testing Full Scale Unit in people with Aging Problems, run by Klein Buendel, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The mission of corrections is to provide custody, control and care for incarcerated individuals. United States prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aging Problems
What is being tested?
Full Scale Unit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
2 sitesUnited States
Study dates
1 Apr 2017to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Employed by a participating state or federal prison
  • Able to speak English
  • Able to consent

Who cannot join

  • Under 18 years
  • Not employed by a participating state or federal prison
  • Unable to speak English
  • Unable to consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Klein Buendel, Inc.

    Golden, Colorado, 80401

  • Penn State University

    University Park, Pennsylvania, 16801

Other trials in United States

About this study

Official title: Enhancing Care of the Aged and Dying in Prisons Phase II

The mission of corrections is to provide custody, control and care for incarcerated individuals. United States prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase II project focuses on the correct users accessing correct learning strategies in the correct setting (i.e., interdisciplinary prison staff accessing high quality products designed to educate and lead practice change initiatives within the walls of prisons), by continuing research and development of a learning system that promotes an integrated systems approach to enhancing the care of the aged and dying in prisons.

Read the detailed description

The United States has the highest rate of incarceration in the world. There are over 1,821 state and federal prisons housing over 2.3 million prisoners in the United States. The demographics of the prison population are shifting. Longer sentences and constrained options for early release compound this trend. The older adult segment of prison populations has more than tripled since 1990. The health status of aging inmates does not mirror the free-world population. In fact, prisoners typically present with health issues common to free citizens who are 10-15 years their senior. Prisoners are wards of that state, that is, the system is responsible for providing for not only custody and control of offenders, but also their care. Collectively, these trends have had a profound impact on prison systems: U.S. prisons are facing sharply increased demands in caring for aged and dying inmates. In response to this need, Phase I project Enhancing Care for the Aged and Dying in Prisons (ECAD-P) demonstrated that (1) there is a need and interest for products such as ECAD-P (i.e., corrections administrators and staff are interested in end-of-life (EOL) care training); (2) trainings should be short, intensive, engaging, interactive, and contextually sensitive to the specific environment; and (3) an interactive, media-rich prototype with high acceptability and usability could be developed. The specification document and commercialization plan indicate it is possible to develop a full-scale ECAD-P learning system in Phase II and market potential exists. The technological innovation proposed for the ECAD-P project is well-suited to the targeted market. Technical merit, feasibility, and market potential of the ECAD-P Learning System were demonstrated in the Phase I project. The purpose of this Phase II application is to continue research and development of the ECAD-P learning system with an emphasis on developing a scalable unit for commercialization and testing scale-up in a larger number of more diverse contexts. More specifically, the aims of ECAD-P Phase II are to 1) Develop a full scale media-rich interactive computer-based learning system consisting of six modules addressing EOL and geriatric care issues in prisons; 2) Conduct in-person usability testing of the full scale ECAD-P Learning System in state and federal prisons to evaluate the user interface, ease of use, and perceived barriers in order to optimize the scalable unit for broader dissemination; and 3) Test scale-up of the full scale ECAD-P Learning System in 12 federal (n=6) and state (n=6) prisons across the nation to evaluate outcomes, usage patterns, and commercialization opportunities. Continued research and development will permit the refinement the scalable unit for commercialization. Expanded testing of the learning system will establish the effectiveness of the learning system and will provide critical insights relevant to dissemination of the commercial product.

Conditions
Aging Problems
Being tested
Full Scale Unit
Keywords
Prisoners, End-of-life care, Geriatric care, Palliative care, Hospice care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full Scale UnitOther

    Pre-test, usability, post-test

Study groups in NCT03055429
Study groupRoleWhat they receive
Full Scale UnitExperimentalTesting of 6 modules
Receives: Other: Full Scale Unit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of knowledge from Baseline (pre-test) to post-test (4-months). (End-of-Life and geriatric-related knowledge)

    A questionnaire will be developed using the content expertise of study personnel and consultants. The questionnaire will evaluate the change in knowledge of geriatric-related and end-of-life prior to the training (pre-test) and at the end of the training (post-test @ 4 months)

    Measured: Pre-test and Post-test (4-months)

Secondary outcomes (4)
  1. Environmental Survey via questionnaire

    Evaluation of support systems and prison environment.

    Measured: 6 months

  2. Environmental Survey via Qualitative Interviews

    Evaluation of support systems and prison environment.

    Measured: 6 months

  3. Survey of past users of the Toolkit for Enhancing End-of-Life Care in Prisons

    Explore the experiences of early adopters of the original Toolkit.

    Measured: 6 months

  4. System Usability Questionnaire

    The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2017
  2. Study start1 Apr 2017
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03055429
Sponsor's protocol ID
0314
Other IDs
2R42AG049570-02
Status last verified
Feb 2023
First submitted
13 Dec 2016
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wagner P, Sakala L. Mass incarceration: the whole pie. Northampton, MA: Prison Policy Initiative. Available at: Retrieved from: http://www.prisonpolicy.org/reports/pie.html. Published 2014. Updated.

  • Williams BA, Goodwin JS, Baillargeon J, Ahalt C, Walter LC. Addressing the aging crisis in U.S. criminal justice health care. J Am Geriatr Soc. 2012 Jun;60(6):1150-6. doi: 10.1111/j.1532-5415.2012.03962.x. Epub 2012 May 29.

    PubMed 22642489
  • Aday RH. Aging prisoners : crisis in American corrections. Westport, Conn.: Praeger; 2003.

Questions about this trial

What is this clinical trial studying?

A study testing Full Scale Unit in people with Aging Problems, run by Klein Buendel, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of knowledge from Baseline (pre-test) to post-test (4-months). (End-of-Life and geriatric-related knowledge) (time frame: Pre-test and Post-test (4-months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055429, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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