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Guardians Receiving Information Through Navigators (GRIN)

K

KDH Research & Communication

Status

Enrolling

Conditions

Community Health Workers
Child
Adolescent
Oral Health
High-risk

Treatments

Other: Treatment 1: Full GRIN course (Lessons 1-8)
Other: Treatment 2: Part 1 of GRIN (Lessons 1-4)
Other: Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT07147244
2025-02-04
5R44MD016352-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

Full description

The investigators will use a randomized, multi-group, pretest/posttest/follow-up design to test the efficacy of the Guardians Receiving Information Through Navigators (GRIN) course and explore the following research question: To what extent does exposure to the GRIN course relate to positive changes in community health workers' (CHWs') knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians?

GRIN course will have eight full course lessons with text, video vignettes, and artificial intelligence (AI) avatar simulations. The study will consist of pretest, posttest, and 3-month follow-up surveys. CHWs assigned to the treatment group will be exposed to different doses of the intervention, including the full GRIN course (Lessons 1-8), Part 1 of GRIN (Lessons 1-4), or Part 2 of GRIN (Lesson1, 5-8). CHWs assigned to the control group will receive pages from the American Dental Association (ADA) website.

Researchers worked with subject matter experts, dental providers, and the intended audience to ensure the GRIN course reflects the specific needs of CHWs providing outreach to guardians of high-risk adolescents; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to improve their outreach skills.

The Principal Investigator (PI), with input from the subject matter experts and dental providers, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDH Research & Communication (KDHRC) Institutional Review Board before the evaluation launch.

Investigators will recruit participants through a multi-pronged recruitment strategy including 1) hiring a contractor to manage recruitment of CHWs by sharing study information and consent process to community-based organizations (CBOs) and other CHW organizations; 2) sharing the opportunity through the KDHRC CHW panel, which notifies subscribed CHWs about research opportunities; 3) recruiting at CHW conferences such as the National Association of Community Health Workers (NACHW) Annual Conference; and 4) posting on social media. Notifications and flyers will provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.

The study will include up to 320 CHWs nationwide (160 treatment groups, 160 control groups). The recruitment contractor and sites will refer participants and may have access to potential participant information (e.g., name, email address) from their listservs, but will not have knowledge of who actually serves as study participants and will not have access to enrolled participants' data. KDHRC will remind participants that participation in the study is completely voluntary, that the referral sites will not have knowledge of who actually serves as study participants, and that his or her participation is no way tied to his or her position at and/or relationship with the site that shared referral materials with him or her.

Investigators will confirm consent for each participant and after confirming consent, will send participants the link to complete the pretest survey. Once the investigators receive the pretest survey, they will randomize each participant into the treatment group or control group using a 1:1 randomization. Investigators will alternate assigning each participant with completed pretest to the treatment groups or the control groups. Then, investigators will provide each treatment group participant with access to appropriate treatment link. The control group will be directed to ADA webpages. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.

The investigators will download and export the data from Alchemer into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest, and follow-up responses using the non-personal identifiers and conduct analyses to test for the effect of the GRIN course exposure on changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income guardians of high-risk adolescents.

The initial evaluation criterion is: Statistically significant (p<0.05) and positive relationship between exposure to GRIN course and increased knowledge among the intervention group in comparison to the control group.

Enrollment

320 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Must be at least 18 years old.
  • Must have six months of field experience. Investigators define "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
  • Must be an active CHW/health educator/individual who conducts health outreach. Investigators define "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
  • Must have Internet access either at home or at work (or at in-person session).

Exclusion criteria

  • none

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 6 patient groups

Treatment 1: Full GRIN course (Lessons 1-8)
Experimental group
Description:
Lessons 1-8 of professional development training course for CHWs on dental health (GRIN)
Treatment:
Other: Treatment 1: Full GRIN course (Lessons 1-8)
Treatment 2: Part 1 of GRIN (Lessons 1-4)
Experimental group
Description:
Lessons 1-4 of professional development training course for CHWs on dental health (GRIN)
Treatment:
Other: Treatment 2: Part 1 of GRIN (Lessons 1-4)
Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
Experimental group
Description:
Lesson 1, 5-8 of professional development training course for CHWs on dental health (GRIN)
Treatment:
Other: Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
Control 1
No Intervention group
Description:
No intervention
Control 2
No Intervention group
Description:
No intervention
Control 3
No Intervention group
Description:
No intervention

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kristen D. Holtz

Data sourced from clinicaltrials.gov

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