Organ DonationPdDNCT04007419
Health Promoters and Organ Donation
A study testing Health Promoters and Organ Donation in people with Organ Donation and Donor Designation/Registration, run by Temple University at 1 site in United States.
Trial summary
Older Hispanics (age 50+ years) are disproportionately overrepresented on the transplant waitlist, but underrepresented as deceased donors and transplant recipients. This application proposes the formative research to design and empirically test an eLearning module, Promotoras de Donación, to train community health… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Organ Donation, Donor Designation/Registration
- What is being tested?
- Health Promoters and Organ Donation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 27 Apr 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lay health educators (Promotora): Lay health educators must be at least 18 years of age, have completed all required Promotoras training, and have actively worked with the local Hispanic community within 3 months of recruitment.
- Mature Latina: Eligible women must be at least 50 years of age, with no obvious cognitive impairment.
Who cannot join
- Lay health educators (Promotora): Untrained lay health educators or those currently in training at their respective organizations will be deemed ineligible, as will individuals who are not actively working as a Promotora at the time of recruitment/enrollment.
- Mature Latina: Hispanic women under the age of 50, or those with obvious cognitive impairment will be deemed ineligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promotoras de Donación: Leveraging Community Health Workers to Increase Donor Registration of Older Hispanics
Older Hispanics (age 50+ years) are disproportionately overrepresented on the transplant waitlist, but underrepresented as deceased donors and transplant recipients. This application proposes the formative research to design and empirically test an eLearning module, Promotoras de Donación, to train community health workers (i.e., Promotoras), who already provide culturally and linguistically sensitive services to their communities, to discuss and promote organ donation with older Hispanic women in 3 geographically distinct communities across the U.S. The proposed intervention leverages the established and evidence-based Promotoras program to increase rates of donor designation within Hispanic communities across the U.S. and reduce disparities in access to transplantation for this population.
Read the detailed description
Despite consistently positive attitudes toward organ donation, increasing the number of registered organ donors in the US continues to challenge the professional and research communities. Improving rates of donor designation among ethnic minorities is of particular importance given the need to match donated organs to recipients on blood type and human leukocyte antigens - the best matches are found when the donor and recipient are of the same ethnic background. In Hispanic communities, lay health educators (i.e., Promotoras) are trained to promote behaviors that empower and enable constituents to prevent disease, and increase control over and improve their health. In partnership with leadership of four Promotoras organizations in geographically diverse areas of the U.S. (PA, IL, TX) representing the largest subgroups of the Hispanic population, this pilot study proposes to leverage the preexisting network of lay health educators to advocate for organ donation and promote donor registration (first person consent) among female Hispanics over the age of 50. Specifically, this study will collect the formative data needed to design an educational and behavioral communication eLearning module for Promotoras and test the impact of the training on Promotoras' knowledge of organ donation, confidence discussing and promoting donor registration, and efficacy increasing rates of donor registration among mature and older Hispanic women. Focus group interviews with Hispanic women and Promotoras will identify the information needs and concerns about organ donation registration of these two groups; interviews with lay educators will also gauge interactivity preferences as well as content and design issues for the resulting web-based training (Aim 1). These data will be used to develop an eLearning module to educate Promotoras about organ donation and train them to discuss donation and promote donor registration (Aim 2). A brief quantitative survey will assess the impact of the module on knowledge of organ donation and confidence (communication self-efficacy) discussing donation and promoting donor designation. We will evaluate Promotoras' efficacy promoting organ donation by assessing the number of Hispanic women age 50 and over who register as posthumous organ donors as a proportion of all women attending small group sessions led by trained Promotoras (Aim 3). If effective, the eLearning module could easily be disseminated nationally to train Promotoras to discuss and promote organ donation. Ultimately, this 'train-the-trainer' study has the potential to increase rates of donor registration among Hispanic communities in the U.S. and help to reduce disparities in access to transplantation for this population.
- Conditions
- Organ Donation, Donor Designation/Registration
- Being tested
- Health Promoters and Organ Donation
- Keywords
- Organ donation, Donor designation/registration, Train-the-trainer, Promotora, Community health worker, Lay health educator, Program development, Program evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promoters and Organ DonationBehavioural
Also called Promotoras de Donación (PdD)
Promotoras de Donación is a highly engaging and interactive online learning experience, that accommodates multiple learning styles by incorporating a variety of pedagogic approaches. The module consists of two components: a didactic educational component and a skills-based communication component. The didactic component provides basic information about organ donation and transplantation and the need for donors in the Hispanic community, and addresses concerns about donation commonly held by older Latina. The skills-based component provides instruction on the key communication skills needed to effectively engage small groups in discussions about organ donation. This component is intended to build communication self-efficacy or confidence opening the discussion about donation, addressing concerns raised by mature and older women participating in the small group sessions, and promoting the act of donor registration using persuasive, but non-coercive language.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | The Promotoras de Donación eLearning module will be launched and 40 participating lay health educators trained. Access to the module will be provided via a link to the website embedded in an announcement email. To assess the impact of the Promotoras de Donación eLearning module on lay health educators' knowledge of organ donation and the need for Hispanic donors, and confidence communicating about donation and promoting the act of donor registration, participating lay health educators will complete a brief online survey upon enrollment (pre) and after completing the module (post). Then, trained lay health educators will hold at least 2 small group sessions with mature Latina (6-8 per session); in all, 80 sessions are anticipated with 480 to 640 mature Latina. Participating mature Latina will complete anonymous paper-pencil surveys before and after each session to assess changes in attitudes toward organ donation and donor registration and intent to register as posthumous organ donors. Receives: Behavioral: Health Promoters and Organ Donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor registration
The proportion of mature Latina attending the trained lay health educator-led small group sessions who also register their intent to become a posthumous organ, tissue and eye donor
Measured: 3 months
Secondary outcomes (2)
Communication self-efficacy
Lay health educators will be asked to rate their level of confidence managing 10 communication skills relevant to discussing organ donation and promoting donor registration along numerical scales ranging from 0 (not at all confident) to 100 (totally confident). A global self-efficacy score will be obtained by summing the ratings for each item.
Measured: 3 months
Knowledge of organ donation
A series of 10 true/false questions previously developed and used to assess knowledge of organ donation in a community sample of Hispanic Americans. A global knowledge score will be created as the sum of all correctly answered questions, ranging from 0 to 10.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Sep 2016
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (91)Papers the sponsor has linked to this study.
- Other trials for Organ DonationStudies 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
- Model description
- The study includes focus group interviews with mature Latina and Promotora to inform the development of a web-based educational and communication intervention, as well as an evaluation of the intervention using a nonrandomized, quasi-experimental pragmatic design, pre-post only with no control group to test the impact of the eLearning module on lay health educators' knowledge of organ donation and confidence holding discussions about and promoting organ donation. Additionally, we will examine the impact of the Promotoras de Donación intervention, which will engage trained lay health educators to lead small group sessions with mature Latina, on the women's attitudes about organ donation and donor registration, and rates of donor registration.
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather M Gardiner (Traino), PhD, MPH, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007419
- Sponsor's protocol ID
- R39OT29878
- Acronym
- PdD
- Status last verified
- Apr 2020
- First submitted
- 11 Jun 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made available for use by written request to the Principal Investigator. Specifically, focus group and survey data collected from lay health educators and mature Latina will be shared in ways in which participants' privacy and confidentiality are secured. Any identifying information in the data will be redacted before sharing. In an effort to provide further protection from the deductive identification of participants, parties requesting data will be asked to agree to use the data solely for research purposes, to refrain from identifying participants in any manner, to secure the data electronically through encryption and/or password protection, and to return or destroy the data upon completion of the analyses.
Publications
Christmas AB, Mallico EJ, Burris GW, Bogart TA, Norton HJ, Sing RF. A paradigm shift in the approach to families for organ donation: honoring patients' wishes versus request for permission in patients with Department of Motor Vehicles donor designations. J Trauma. 2008 Dec;65(6):1507-9; discussion 1509-10. doi: 10.1097/TA.0b013e31818a5cf0.
PubMed 19077650Traino HM, Siminoff LA. Attitudes and acceptance of First Person Authorization: a national comparison of donor and nondonor families. J Trauma Acute Care Surg. 2013 Jan;74(1):294-300. doi: 10.1097/TA.0b013e318270dafc.
PubMed 23147186Siminoff LA, Agyemang AA, Traino HM. Consent to organ donation: a review. Prog Transplant. 2013 Mar;23(1):99-104. doi: 10.7182/pit2013801.
PubMed 23448829Gallup Organization. The American public's attitudes toward organ donation and transplantation. Boston: The Partnership for Organ Donation; 1993.
U.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, 2012 National Survey of Organ Donation Attitudes and Behaviors. Rockville, Maryland: U.S. Department of Health and Human Services, 2013.
United States Renal Data System. 2015 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2015.
Hoerger TJ, Simpson SA, Yarnoff BO, Pavkov ME, Rios Burrows N, Saydah SH, Williams DE, Zhuo X. The future burden of CKD in the United States: a simulation model for the CDC CKD Initiative. Am J Kidney Dis. 2015 Mar;65(3):403-11. doi: 10.1053/j.ajkd.2014.09.023. Epub 2014 Nov 5.
PubMed 25468386Grams ME, Chow EK, Segev DL, Coresh J. Lifetime incidence of CKD stages 3-5 in the United States. Am J Kidney Dis. 2013 Aug;62(2):245-52. doi: 10.1053/j.ajkd.2013.03.009. Epub 2013 Apr 6.
PubMed 23566637Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011 May;20(3):241-5. doi: 10.1097/MNH.0b013e3283454319.
PubMed 21422925Scaglione S, Kliethermes S, Cao G, Shoham D, Durazo R, Luke A, Volk ML. The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin Gastroenterol. 2015 Sep;49(8):690-6. doi: 10.1097/MCG.0000000000000208.
PubMed 25291348Lim YS, Kim WR. The global impact of hepatic fibrosis and end-stage liver disease. Clin Liver Dis. 2008 Nov;12(4):733-46, vii. doi: 10.1016/j.cld.2008.07.007.
PubMed 18984463Lazo M, Hernaez R, Eberhardt MS, Bonekamp S, Kamel I, Guallar E, Koteish A, Brancati FL, Clark JM. Prevalence of nonalcoholic fatty liver disease in the United States: the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Epidemiol. 2013 Jul 1;178(1):38-45. doi: 10.1093/aje/kws448. Epub 2013 May 23.
PubMed 23703888Kim HJ, Lee HW. Important predictor of mortality in patients with end-stage liver disease. Clin Mol Hepatol. 2013 Jun;19(2):105-15. doi: 10.3350/cmh.2013.19.2.105. Epub 2013 Jun 27.
PubMed 23837134Ahmed A, Keeffe EB. Current indications and contraindications for liver transplantation. Clin Liver Dis. 2007 May;11(2):227-47. doi: 10.1016/j.cld.2007.04.008.
PubMed 17606204Rein DB, Wittenborn JS, Weinbaum CM, Sabin M, Smith BD, Lesesne SB. Forecasting the morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the United States. Dig Liver Dis. 2011 Jan;43(1):66-72. doi: 10.1016/j.dld.2010.05.006. Epub 2010 Jun 17.
PubMed 20739252
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotoras de Donación: Leveraging Community Health Workers to Increase Donor Registration of Older Hispanics
- ClinicalTrials.gov ID
- NCT04007419
- Acronym / sponsor ID
- PdD / R39OT29878
- Conditions
- Organ Donation, Donor Designation/Registration
- Keywords
- Organ donation, Donor designation/registration, Train-the-trainer, Promotora, Community health worker, Lay health educator, Program development, Program evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 5 Jul 2019 (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.
Older Hispanics (age 50+ years) are disproportionately overrepresented on the transplant waitlist, but underrepresented as deceased donors and transplant recipients. This application proposes the formative research to design and empirically test an eLearning module, Promotoras de Donación, to train community health workers (i.e., Promotoras), who already provide culturally and linguistically sensitive services to their communities, to discuss and promote organ donation with older Hispanic women in 3 geographically distinct communities across the U.S. The proposed intervention leverages the established and evidence-based Promotoras program to increase rates of donor designation within Hispanic communities across the U.S. and reduce disparities in access to transplantation for this population.
Detailed description
Despite consistently positive attitudes toward organ donation, increasing the number of registered organ donors in the US continues to challenge the professional and research communities. Improving rates of donor designation among ethnic minorities is of particular importance given the need to match donated organs to recipients on blood type and human leukocyte antigens - the best matches are found when the donor and recipient are of the same ethnic background. In Hispanic communities, lay health educators (i.e., Promotoras) are trained to promote behaviors that empower and enable constituents to prevent disease, and increase control over and improve their health. In partnership with leadership of four Promotoras organizations in geographically diverse areas of the U.S. (PA, IL, TX) representing the largest subgroups of the Hispanic population, this pilot study proposes to leverage the preexisting network of lay health educators to advocate for organ donation and promote donor registration (first person consent) among female Hispanics over the age of 50. Specifically, this study will collect the formative data needed to design an educational and behavioral communication eLearning module for Promotoras and test the impact of the training on Promotoras' knowledge of organ donation, confidence discussing and promoting donor registration, and efficacy increasing rates of donor registration among mature and older Hispanic women. Focus group interviews with Hispanic women and Promotoras will identify the information needs and concerns about organ donation registration of these two groups; interviews with lay educators will also gauge interactivity preferences as well as content and design issues for the resulting web-based training (Aim 1). These data will be used to develop an eLearning module to educate Promotoras about organ donation and train them to discuss donation and promote donor registration (Aim 2). A brief quantitative survey will assess the impact of the module on knowledge of organ donation and confidence (communication self-efficacy) discussing donation and promoting donor designation. We will evaluate Promotoras' efficacy promoting organ donation by assessing the number of Hispanic women age 50 and over who register as posthumous organ donors as a proportion of all women attending small group sessions led by trained Promotoras (Aim 3). If effective, the eLearning module could easily be disseminated nationally to train Promotoras to discuss and promote organ donation. Ultimately, this 'train-the-trainer' study has the potential to increase rates of donor registration among Hispanic communities in the U.S. and help to reduce disparities in access to transplantation for this population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study includes focus group interviews with mature Latina and Promotora to inform the development of a web-based educational and communication intervention, as well as an evaluation of the intervention using a nonrandomized, quasi-experimental pragmatic design, pre-post only with no control group to test the impact of the eLearning module on lay health educators' knowledge of organ donation and confidence holding discussions about and promoting organ donation. Additionally, we will examine the impact of the Promotoras de Donación intervention, which will engage trained lay health educators to lead small group sessions with mature Latina, on the women's attitudes about organ donation and donor registration, and rates of donor registration.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Health Promoters and Organ DonationThe Promotoras de Donación eLearning module will be launched and 40 participating lay health educators trained. Access to the module will be provided via a link to the website embedded in an announcement email. To assess the impact of the Promotoras de Donación eLearning module on lay health educators' knowledge of organ donation and the need for Hispanic donors, and confidence communicating about donation and promoting the act of donor registration, participating lay health educators will complete a brief online survey upon enrollment (pre) and after completing the module (post). Then, trained lay health educators will hold at least 2 small group sessions with mature Latina (6-8 per session); in all, 80 sessions are anticipated with 480 to 640 mature Latina. Participating mature Latina will complete anonymous paper-pencil surveys before and after each session to assess changes in attitudes toward organ donation and donor registration and intent to register as posthumous organ donors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lay health educators (Promotora): Lay health educators must be at least 18 years of age, have completed all required Promotoras training, and have actively worked with the local Hispanic community within 3 months of recruitment.
- Mature Latina: Eligible women must be at least 50 years of age, with no obvious cognitive impairment.
Key exclusion criteria (2 listed)
- Lay health educators (Promotora): Untrained lay health educators or those currently in training at their respective organizations will be deemed ineligible, as will individuals who are not actively working as a Promotora at the time of recruitment/enrollment.
- Mature Latina: Hispanic women under the age of 50, or those with obvious cognitive impairment will be deemed ineligible.
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 |
|---|---|---|
| Health Promoters and Organ DonationAlso: Promotoras de Donación (PdD)Promotoras de Donación is a highly engaging and interactive online learning experience, that accommodates multiple learning styles by incorporating a variety of pedagogic approaches. The module consists of two components: a didactic educational component and a skills-based communication component. The didactic component provides basic information about organ donation and transplantation and the need for donors in the Hispanic community, and addresses concerns about donation commonly held by older Latina. The skills-based component provides instruction on the key communication skills needed to effectively engage small groups in discussions about organ donation. This component is intended to build communication self-efficacy or confidence opening the discussion about donation, addressing concerns raised by mature and older women participating in the small group sessions, and promoting the act of donor registration using persuasive, but non-coercive language. | Behavioural | Single Arm |
Primary outcome
Donor registration
Time frame: 3 months
The proportion of mature Latina attending the trained lay health educator-led small group sessions who also register their intent to become a posthumous organ, tissue and eye donor
2 secondary outcomes
Communication self-efficacy
Time frame: 3 months
Knowledge of organ donation
Time frame: 3 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 1 May 2020.
- Background: PubMed 19077650Christmas AB, Mallico EJ, Burris GW, Bogart TA, Norton HJ, Sing RF. A paradigm shift in the approach to families for organ donation: honoring patients' wishes versus request for permission in patients with Department of Motor Vehicles donor designations. J Trauma. 2008 Dec;65(6):1507-9; discussion 1509-10. doi: 10.1097/TA.0b013e31818a5cf0.
- Background: PubMed 23147186Traino HM, Siminoff LA. Attitudes and acceptance of First Person Authorization: a national comparison of donor and nondonor families. J Trauma Acute Care Surg. 2013 Jan;74(1):294-300. doi: 10.1097/TA.0b013e318270dafc.
- Background: PubMed 23448829Siminoff LA, Agyemang AA, Traino HM. Consent to organ donation: a review. Prog Transplant. 2013 Mar;23(1):99-104. doi: 10.7182/pit2013801.
- BackgroundGallup Organization. The American public's attitudes toward organ donation and transplantation. Boston: The Partnership for Organ Donation; 1993.
- BackgroundU.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, 2012 National Survey of Organ Donation Attitudes and Behaviors. Rockville, Maryland: U.S. Department of Health and Human Services, 2013.
- BackgroundUnited States Renal Data System. 2015 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2015.
- Background: PubMed 25468386Hoerger TJ, Simpson SA, Yarnoff BO, Pavkov ME, Rios Burrows N, Saydah SH, Williams DE, Zhuo X. The future burden of CKD in the United States: a simulation model for the CDC CKD Initiative. Am J Kidney Dis. 2015 Mar;65(3):403-11. doi: 10.1053/j.ajkd.2014.09.023. Epub 2014 Nov 5.
- Background: PubMed 23566637Grams ME, Chow EK, Segev DL, Coresh J. Lifetime incidence of CKD stages 3-5 in the United States. Am J Kidney Dis. 2013 Aug;62(2):245-52. doi: 10.1053/j.ajkd.2013.03.009. Epub 2013 Apr 6.
- Background: PubMed 21422925Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011 May;20(3):241-5. doi: 10.1097/MNH.0b013e3283454319.
- Background: PubMed 25291348Scaglione S, Kliethermes S, Cao G, Shoham D, Durazo R, Luke A, Volk ML. The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin Gastroenterol. 2015 Sep;49(8):690-6. doi: 10.1097/MCG.0000000000000208.
- Background: PubMed 18984463Lim YS, Kim WR. The global impact of hepatic fibrosis and end-stage liver disease. Clin Liver Dis. 2008 Nov;12(4):733-46, vii. doi: 10.1016/j.cld.2008.07.007.
- Background: PubMed 23703888Lazo M, Hernaez R, Eberhardt MS, Bonekamp S, Kamel I, Guallar E, Koteish A, Brancati FL, Clark JM. Prevalence of nonalcoholic fatty liver disease in the United States: the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Epidemiol. 2013 Jul 1;178(1):38-45. doi: 10.1093/aje/kws448. Epub 2013 May 23.
- Revised Uniform Anatomical Gift Act (2006). Last Revised or Amended in 2009. National Conference of Commissioners of Uniform State LawsLink provided by the sponsor.
- Donate Life America. 2015 Annual UpdateLink provided by the sponsor.
- U.S. Census Bureau. U.S. Census Bureau projections show a slower growing, older, more diverse nation a half century from nowLink provided by the sponsor.
- U.S. Census Bureau. American Fact FinderLink provided by the sponsor.
- U.S. Department of Health \& Human Services, Office of Minority Health, Think Cultural Health. Promoting Healthy Choices and Community Changes: An E-learning Program for Promotores De SaludLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available for use by written request to the Principal Investigator. Specifically, focus group and survey data collected from lay health educators and mature Latina will be shared in ways in which participants' privacy and confidentiality are secured. Any identifying information in the data will be redacted before sharing. In an effort to provide further protection from the deductive identification of participants, parties requesting data will be asked to agree to use the data solely for research purposes, to refrain from identifying participants in any manner, to secure the data electronically through encryption and/or password protection, and to return or destroy the data upon completion of the analyses.
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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.
Heather M Gardiner (Traino), PhD, MPH principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promoters and Organ Donation in people with Organ Donation and Donor Designation/Registration, run by Temple University at 1 site 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 2 inclusion and 2 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Donor registration (time frame: 3 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 NCT04007419, which also lists 91 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 1 May 2020.