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.
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
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 group | Role | What they receive |
|---|---|---|
| Full Scale Unit | Experimental | Testing 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.
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)
Environmental Survey via questionnaire
Evaluation of support systems and prison environment.
Measured: 6 months
Environmental Survey via Qualitative Interviews
Evaluation of support systems and prison environment.
Measured: 6 months
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
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.
- First posted16 Feb 2017
- Study start1 Apr 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Penn State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Janice Penrod, PhD, Principal investigator, Penn State University
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 22642489Aday RH. Aging prisoners : crisis in American corrections. Westport, Conn.: Praeger; 2003.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Care of the Aged and Dying in Prisons Phase II
- ClinicalTrials.gov ID
- NCT03055429
- Acronym / sponsor ID
- 0314
- Conditions
- Aging Problems
- Keywords
- Prisoners, End-of-life care, Geriatric care, Palliative care, Hospice care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Penn State University, National Institute on Aging (NIA)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Scale Unit | Experimental | Other: Full Scale UnitTesting of 6 modules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Employed by a participating state or federal prison
- Able to speak English
- Able to consent
Key exclusion criteria (4 listed)
- Under 18 years
- Not employed by a participating state or federal prison
- Unable to speak English
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Scale UnitPre-test, usability, post-test | Other | Full Scale Unit |
Primary outcome
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)
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)
4 secondary outcomes
Environmental Survey via questionnaire
Time frame: 6 months
Environmental Survey via Qualitative Interviews
Time frame: 6 months
Survey of past users of the Toolkit for Enhancing End-of-Life Care in Prisons
Time frame: 6 months
System Usability Questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- BackgroundWagner 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.
- Background: PubMed 22642489Williams 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.
- BackgroundAday RH. Aging prisoners : crisis in American corrections. Westport, Conn.: Praeger; 2003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Penrod, PhD principal investigator
Penn State University
2 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.