Aging ProblemsP2PNCT03323008
E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons
A study testing Prototype 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 care, custody, and control for incarcerated individuals. United State 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?
- Prototype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 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
Inmate Inclusion Criteria:
- Be a Mental Health Peer Support Specialist
- Be 18 years or older
- Able to speak, understand, and read English
- Able to consent.
Inmate Exclusion Criteria:
- Not be a Mental Health Peer Support Specialist
- Under 18 years of age
- Unable to speak, understand, and read English
- Unable to consent.
Prison Employee Inclusion Criteria:
- 18 years or older
- Employed by a participating at a participating prison
- Able to speak, understand, and read English
- Able to consent
Prison Employee Exclusion Criteria:
- Under 18 years
- Not employed by a participating 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
The mission of corrections is to provide care, custody, and control for incarcerated individuals. United State 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 I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in prisons.
Read the detailed description
The US has the highest incarceration rate in the world-imprisoning 693 people per 100,000. The older adult segment of the prison population has more than tripled since 1990 and their health issues are common to free people who are 10-15 years their senior. Inmates over the age of 55 have a death rate that is 10 times that of prisoners aged 25-34. US prison systems are facing sharply increased demands in caring for aged and dying inmates. A recent systematic review revealed that inmate peer caregivers can figure prominently in delivery of end-of-life (EOL) care in prison. However, the degree of training received by inmate peer caregivers varies widely. The lack of consistent training, both in content and duration points to a need for evidence based, current, and readily accessible training for this abundant human resource for meeting a growing need in US prisons. In response to this need, this Phase I STTR project, titled E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-Life Care in Prisons, will demonstrate the scientific merit and feasibility of developing cutting edge, media rich learning modules to train inmate peer caregivers in geriatric and EOL care. The specific aims of the project are to (1) transform best practices in inmate peer caregiving into a comprehensive training program that consists of media-rich and highly interactive computer-based learning modules for providing geriatric and EOL care to their peers; and (2) conduct in-person usability testing of the media-rich and highly interactive web-based prototypes with inmates who are currently Mental Health Peer Support Specialists (i.e., prisoners who are experienced caregivers, but naïve to geriatric and EOL care) to evaluate the user interface, ease of use, and perceived barriers in order to refine and optimize the product. In collaboration with an advisory board of experts in prison healthcare, geriatrics, ethics, palliative/hospice care, and oversight of an inmate peer support program, the investigators plan and develop discussion guides and then conduct focus groups with three groups of prison stakeholders: inmates who serve as peer caregivers for aged or dying peers; interdisciplinary staff who care for, or oversee care of aged and dying inmates; and training and information technology staff. One focus group with each of the above three constituent groups will be held at a men's and a women's prison. Focus groups will permit investigators to ensure that the design and technology plans match what is allowable for inmate training and will allow us to isolate essential geriatric and EOL content for specification in the development of the comprehensive training program. Finally, the investigators will create and evaluate prototypes of media rich, interactive computer-based learning modules for inmates serving as peer caregivers. At the end of Phase I, the investigators will have a specifications document for the design of modules that: fit with the technology available in corrections settings; is permissible to be used by inmates; represents the critical learning needs of inmate peer caregivers for assisting with geriatric and EOL care; and further develops the collaborative relationships in preparation for commercialization of the product.
- Conditions
- Aging Problems
- Being tested
- Prototype
- Keywords
- Prisoners, End-of-life Care, Geriatric Care, Palliative Care, Hospice Care, Prison, Corrections, Inmates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrototypeOther
Usability testing and System Usability Scale
| Study group | Role | What they receive |
|---|---|---|
| Training Prototype | Experimental | Testing of 3 modules Receives: Other: Prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products. It contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." A score of 68 is considered "above average." Anything below a 68 is considered "below average." The higher the score, the higher the usability of the product.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Nov 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 (4)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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Penn State University
- Responsible party
- Sponsor
- Investigators
- Valerie Myers, PHD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323008
- Sponsor's protocol ID
- 1R41AG057239-01
- Other IDs
- 1R41AG057239-01, 03017
- Acronym
- P2P
- Status last verified
- Dec 2019
- First submitted
- 24 Oct 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loeb SJ, Steffensmeier D, Lawrence F. Comparing incarcerated and community-dwelling older men's health. West J Nurs Res. 2008 Mar;30(2):234-49; discussion 250-8. doi: 10.1177/0193945907302981. Epub 2007 Jul 13.
PubMed 17630382Noonan M, Ginder S. Mortality in local jails and state prisons, 2000-2012-statistical table. Washington, DC: US Department of Justice, Office of Justice Programs, Bureau of Justice Statistics. October 2014.
Wion RK, Loeb SJ. CE: Original Research: End-of-Life Care Behind Bars: A Systematic Review. Am J Nurs. 2016 Mar;116(3):24-36; quiz 37. doi: 10.1097/01.NAJ.0000481277.99686.82.
PubMed 26871892Cloyes KG, Rosenkranz SJ, Berry PH, Supiano KP, Routt M, Shannon-Dorcy K, Llanque SM. Essential Elements of an Effective Prison Hospice Program. Am J Hosp Palliat Care. 2016 May;33(4):390-402. doi: 10.1177/1049909115574491. Epub 2015 Mar 2.
PubMed 25735806
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons
- ClinicalTrials.gov ID
- NCT03323008
- Acronym / sponsor ID
- P2P / 1R41AG057239-01
- Conditions
- Aging Problems
- Keywords
- Prisoners, End-of-life Care, Geriatric Care, Palliative Care, Hospice Care, Prison, Corrections, Inmates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Penn State University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 26 Oct 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 care, custody, and control for incarcerated individuals. United State 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 I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in prisons.
Detailed description
The US has the highest incarceration rate in the world-imprisoning 693 people per 100,000. The older adult segment of the prison population has more than tripled since 1990 and their health issues are common to free people who are 10-15 years their senior. Inmates over the age of 55 have a death rate that is 10 times that of prisoners aged 25-34. US prison systems are facing sharply increased demands in caring for aged and dying inmates. A recent systematic review revealed that inmate peer caregivers can figure prominently in delivery of end-of-life (EOL) care in prison. However, the degree of training received by inmate peer caregivers varies widely. The lack of consistent training, both in content and duration points to a need for evidence based, current, and readily accessible training for this abundant human resource for meeting a growing need in US prisons. In response to this need, this Phase I STTR project, titled E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-Life Care in Prisons, will demonstrate the scientific merit and feasibility of developing cutting edge, media rich learning modules to train inmate peer caregivers in geriatric and EOL care. The specific aims of the project are to (1) transform best practices in inmate peer caregiving into a comprehensive training program that consists of media-rich and highly interactive computer-based learning modules for providing geriatric and EOL care to their peers; and (2) conduct in-person usability testing of the media-rich and highly interactive web-based prototypes with inmates who are currently Mental Health Peer Support Specialists (i.e., prisoners who are experienced caregivers, but naïve to geriatric and EOL care) to evaluate the user interface, ease of use, and perceived barriers in order to refine and optimize the product. In collaboration with an advisory board of experts in prison healthcare, geriatrics, ethics, palliative/hospice care, and oversight of an inmate peer support program, the investigators plan and develop discussion guides and then conduct focus groups with three groups of prison stakeholders: inmates who serve as peer caregivers for aged or dying peers; interdisciplinary staff who care for, or oversee care of aged and dying inmates; and training and information technology staff. One focus group with each of the above three constituent groups will be held at a men's and a women's prison. Focus groups will permit investigators to ensure that the design and technology plans match what is allowable for inmate training and will allow us to isolate essential geriatric and EOL content for specification in the development of the comprehensive training program. Finally, the investigators will create and evaluate prototypes of media rich, interactive computer-based learning modules for inmates serving as peer caregivers. At the end of Phase I, the investigators will have a specifications document for the design of modules that: fit with the technology available in corrections settings; is permissible to be used by inmates; represents the critical learning needs of inmate peer caregivers for assisting with geriatric and EOL care; and further develops the collaborative relationships in preparation for commercialization of the product.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Prototype | Experimental | Other: PrototypeTesting of 3 modules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PrototypeUsability testing and System Usability Scale | Other | Training Prototype |
Primary outcome
System Usability Scale
Time frame: 2 months
The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products. It contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." A score of 68 is considered "above average." Anything below a 68 is considered "below average." The higher the score, the higher the usability of the product.
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 10 Dec 2019.
- Background: PubMed 17630382Loeb SJ, Steffensmeier D, Lawrence F. Comparing incarcerated and community-dwelling older men's health. West J Nurs Res. 2008 Mar;30(2):234-49; discussion 250-8. doi: 10.1177/0193945907302981. Epub 2007 Jul 13.
- BackgroundNoonan M, Ginder S. Mortality in local jails and state prisons, 2000-2012-statistical table. Washington, DC: US Department of Justice, Office of Justice Programs, Bureau of Justice Statistics. October 2014.
- Background: PubMed 26871892Wion RK, Loeb SJ. CE: Original Research: End-of-Life Care Behind Bars: A Systematic Review. Am J Nurs. 2016 Mar;116(3):24-36; quiz 37. doi: 10.1097/01.NAJ.0000481277.99686.82.
- Background: PubMed 25735806Cloyes KG, Rosenkranz SJ, Berry PH, Supiano KP, Routt M, Shannon-Dorcy K, Llanque SM. Essential Elements of an Effective Prison Hospice Program. Am J Hosp Palliat Care. 2016 May;33(4):390-402. doi: 10.1177/1049909115574491. Epub 2015 Mar 2.
- Individual participant dataSharing planned: No
Related trials for Aging Problems
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
RecruitingEarly Phase 1
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
Aging, Balance Deficits
Active, not recruiting
Brain Health Virtual Reality Study
Aging, Aging Problems
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.
Valerie Myers, PHD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype 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?
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 10 Dec 2019. 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?
System Usability Scale (time frame: 2 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 NCT03323008, which also lists 4 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 10 Dec 2019.