Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05511935 |
| Other study ID # |
2022-02-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
KDH Research & Communication |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Two arm study, experimental and control, to explore the impact of an online training program
to help community health workers conduct effective outreach to support the dental health of
African American youth via their caregivers.
Description:
The investigators will use a randomized, two-group, pretest/posttest design to test the
efficacy of the GRIN prototype and explore the following research question: To what extent
does exposure to the GRIN prototype relate to positive changes in CHWs' knowledge, attitudes
and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to
low-income Black guardians? The community-driven nature of the project will ground the
evaluation in the principles of an equitable evaluation that incorporates a racial equity
lens. An equitable evaluation is "an approach that addresses the dynamics and practices that
have historically undervalued the voices, knowledge, expertise, capacity, and experiences of
all evaluation participants and stakeholders, particularly people of color and other
marginalized groups." This approach "requires that evaluators engage in a process of ongoing
self-reflection and adjustment, including a willingness to question and adapt traditional
evaluation methods in response to stakeholder input." Working with communities to reflect the
specific needs of their constituents, investigators will develop and enhance collaborations
that leverage stakeholder expertise; minimize counter-productive duplications of services and
resource expenditure; and create empowered opportunities for CHWs to conduct outreach with
low-income Black guardians. The PI, with input from the SC, will develop necessary research
materials, including the recruitment protocols, evaluation instrumentation, and human
subjects consent materials, which then be reviewed against an equitable evaluation checklist,
obtaining input on revisions from community members where needed. The PI will also outline
the appropriate statistical analysis methods. All procedure documents will be reviewed by the
KDHRC Institutional Review Board before the evaluation launch.
The investigators will recruit participants through evaluation partners who will disseminate
the study information to CHWs via electronic notifications and flyers. Evaluation partners
include National Association of Community Health Workers (NACHW) and the University of
Southern Mississippi College of Nursing and Health Professionals (see Letters of Support for
more details). The notification will provide information about the goal of the study,
participant eligibility, and a link to an interest and eligibility form. Once a potential
participant completes the interest and eligibility form and s/he is eligible for the project,
they will receive a link to a consent form located on a secure online platform.
CHWs will be randomly assigned to the intervention or control group after consent and
enrollment in the study. All participants will complete an online pretest survey. The
intervention group will be exposed to GRIN and will complete an online posttest survey two
weeks after completing the GRIN modules. The control group participants will not be exposed
to the GRIN program and will complete a posttest two weeks after completing the pretest.
Participant responses to pretest and posttest survey measures will be linked using
non-personal identifiers.
The investigators will download and export the data from SurveyGizmo into an encrypted Excel
file and import the raw data into STATA. The investigators will match the pretest and
posttest responses using the random assigned identifiers and conduct analyses to test for the
effect of GRIN exposure on changes in CHWs' knowledge, attitudes and beliefs, self-efficacy,
and intentions to conduct pediatric oral health care outreach to low-income Black guardians.
The a priori feasibility criterion is: Statistically significant differences between pretest
and posttest knowledge and self-efficacy measures among the intervention group participants.
