NCT04007419

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
621

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

3.7 years

First QC Date

June 11, 2019

Last Update Submit

April 29, 2020

Conditions

Organ DonationDonor Designation/Registration

Keywords

Organ donationDonor designation/registrationTrain-the-trainerPromotoraCommunity health workerLay health educatorProgram developmentProgram evaluation

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (2)

  • Communication self-efficacy

    3 months

  • Knowledge of organ donation

    3 months

Other Outcomes (3)

  • Donation intentions

    3 months

  • Support for organ donation

    3 months

  • Perceptions of the Promotoras de Donación eLearning module

    3 months

Study Arms (1)

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.

Behavioral: Health Promoters and Organ Donation

Interventions

Health Promoters and Organ DonationBEHAVIORAL

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.

Also known as: Promotoras de Donación (PdD)
Single Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

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  • Alolod GP, Gardiner H, Agu C, Turner JL, Kelly PJ, Siminoff LA, Gordon EJ, Norden R, Daly TA, Benitez A, Hernandez I, Guinansaca N, Winther LR, Bergeron CD, Montalvo A, Gonzalez T. A Culturally Targeted eLearning Module on Organ Donation (Promotoras de Donacion): Design and Development. J Med Internet Res. 2020 Jan 13;22(1):e15793. doi: 10.2196/15793.

    PMID: 31929102DERIVED

Related Links

MeSH Terms

Interventions

Tissue and Organ Procurement

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Heather M Gardiner (Traino), PhD, MPH

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

July 5, 2019

Study Start

September 1, 2016

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data from this study will be available after publication of the study's major findings
Access Criteria
Written request to the Principal Investigator (Heather Gardiner).

Locations

US(1)